Consulting Wallah › Device Explorer › Syringes, needles & infusion › Non-fixed blood collection needle
Device Explorer · FDA GUDID · GMDN 35209

Non-fixed blood collection needle

A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be

US‑registered devices381in commercial distribution
Companies24labelers on GUDID
Single‑use99%of device records
Sterile98%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Guangzhou Improve Medical Instruments Co., Ltd.13134%
Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd287%
Myco Medical Supplies Inc.277%
Medline Industries, Inc.205%
Sarstedt Aktiengesellschaft & Co.Kg185%
Icu Medical, Inc.185%
Cardinal Health, Inc.174%
Meus Srl164%

Top labelers

CompanyDevicesShare
Guangzhou Improve Medical Instruments Co., Ltd.13134%
Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd287%
Myco Medical Supplies Inc.277%
Medline Industries, Inc.205%
Sarstedt Aktiengesellschaft & Co.Kg185%
Icu Medical, Inc.185%
Cardinal Health, Inc.174%
Meus Srl164%
Sol-Millennium Medical, Inc.133%
Marketlab Inc.133%
Nxstage Medical, Inc.103%
Chirana T.Injecta, A. S.103%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IMPROSAFE® Blood Collection Set with Pre-AttacheIMPROSAFE® Blood Collection SetIMPROVACUTER® Blood Collection SetBlood Collection Needle with Needle HolderBlood Collection Needle without Needle HolderSafety Blood Collection Needle (Without Needle HBLUDRAWIMPROVACUTER® Blood Collection Set with Pre-AttIMPROSAFE® Multi Sample Needle (Flashback)IMPROSAFE® Multi Sample Needle"Safety-Needle 23Gx1""""S-Monovette®-Needle 23Gx1"""Micro-NeedleSafety-NeedleS-Monovette®-NeedleMedline

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FMINeedle, Hypodermic, Single Lumen238
JKATubes, Vials, Systems, Serum Separators, Blood Collection63
FMINeedle, hypodermic, single lumen58
JKATubes, vials, systems, serum separators, blood collection24
FMFSyringe, piston14
FOZCatheter,intravascular,therapeutic,short-term less than 30 d13

GMDN & GCC registration

  • GMDN code 35209 · non‑implantable
  • Single‑use 99% · sterile 98% · Rx‑only 54% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 89Length (Inch) · 48Length (Millimeter) · 32Weight (Gram) · 4Total Volume (Milliliter) · 1

Use these as the dimensions to specify in a tender line.

How many non-fixed blood collection needle products are registered in the US?

381 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-fixed blood collection needle", from 24 companies. The largest labeler is Guangzhou Improve Medical Instruments Co., Ltd. with 34% of records.

Which FDA product codes apply?

FMI (Needle, Hypodermic, Single Lumen), JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), FMI (Needle, hypodermic, single lumen), JKA (Tubes, vials, systems, serum separators, blood collection)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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