Device Explorer · FDA GUDID · GMDN 18026

Phlebotomy kit

A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

US‑registered devices327in commercial distribution
Companies14labelers on GUDID
Single‑use98%of device records
Sterile12%labelled sterile
Prescription17%Rx‑only share
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Share of device records

Aero-Med, Llc24776%
Medline Industries, Inc.278%
Cardinal Health 200, Llc196%
Ditek Consulting, Llc113%
Caredx, Inc.62%
Nuo Therapeutics, Inc.41%
Sb-Kawasumi Laboratories, Inc.21%
Cellmedix Holdings, Llc21%

Top labelers

CompanyDevicesShare
Aero-Med, Llc24776%
Medline Industries, Inc.278%
Cardinal Health 200, Llc196%
Ditek Consulting, Llc113%
Caredx, Inc.62%
Nuo Therapeutics, Inc.41%
Sb-Kawasumi Laboratories, Inc.21%
Cellmedix Holdings, Llc21%
Nuo Therapeutics Inc21%
Vygon Corporation21%
Medical Action Industries Inc.21%
Promisemed Hangzhou Meditech Co., Ltd.10%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VerifineK-Shield Advantage Blood Drawing KitProGen Phlebotomy KitPhlebotomy KitCareDxKidneyCare Specimen Collection KitHeartCare Specimen Collection KitAllomap Specimen Collection KitAlloSure Specimen Collection KitSpecimen Collection KitDitek BioBank Kit (Labcorp)Kidney Health Test Kit 3Kidney Health Test Kit 2Kidney Combo Test Kit 1NIPS Single Pack Testing KitQFT Kit

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

FDA product codes

CodeNameDevices
OIBBlood and urine collection kit (excludes HIV testing)461
FMINeedle, hypodermic, single lumen15
OFMPhlebotomy blood collection kit13
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)12
FMFSyringe, piston10
OFMPhlebotomy Blood Collection Kit6

GMDN & GCC registration

  • GMDN code 18026 · non‑implantable
  • Single‑use 98% · sterile 12% · Rx‑only 17% · OTC 78%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 10Weight (Gram) · 10Needle Gauge (Gauge) · 2Total Volume (Milliliter) · 1

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

How many phlebotomy kit products are registered in the US?

327 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Phlebotomy kit", from 14 companies. The largest labeler is Aero-Med, Llc with 76% of records.

Which FDA product codes apply?

OIB (Blood and urine collection kit (excludes HIV testing)), FMI (Needle, hypodermic, single lumen), OFM (Phlebotomy blood collection kit), OIB (Blood And Urine Collection Kit (Excludes Hiv Testing))

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.

How do I get quotes?

Add phlebotomy kit to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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