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Device Explorer · FDA GUDID · GMDN 58497

Blood collection set, invasive

A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a

US‑registered devices631in commercial distribution
Companies54labelers on GUDID
Single‑use100%of device records
Sterile92%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Jiangsu Caina Medical Co.,Ltd457%
Becton, Dickinson And Company427%
Medline Industries, Inc.427%
Kurin, Inc.406%
Medical Action Industries Inc.406%
Myco Medical Supplies Inc.396%
Kb Medical (Group), Inc.366%
Innovative Medical Technologies, Inc.335%

Top labelers

CompanyDevicesShare
Jiangsu Caina Medical Co.,Ltd457%
Becton, Dickinson And Company427%
Medline Industries, Inc.427%
Kurin, Inc.406%
Medical Action Industries Inc.406%
Myco Medical Supplies Inc.396%
Kb Medical (Group), Inc.366%
Innovative Medical Technologies, Inc.335%
Owen Mumford Usa Incorporated325%
Icu Medical, Inc.244%
Sb-Kawasumi Laboratories, Inc.213%
The Monarch Co., Llc203%

Company = labeler of record on GUDID. 54 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HupaiNeedle HolderIMPROSAFE® Blood Collection Set with Pre-AttacheIMPROSAFE® Blood Collection SetIMPROVACUTER® Blood Collection SetUnimedKawasumiCAINASafeTPointWttodMulti-Sample Blood Collection SetBAIXINECLIPSEBDSK-SHIELD ADVANTAGE WINGED BLOOD COLLECTION SET WK-SHIELD ADVANTAGE WINGED COLLECTION SET WITH MU

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

FDA product codes

CodeNameDevices
JKATubes, Vials, Systems, Serum Separators, Blood Collection349
FPASet, Administration, Intravascular179
FMINeedle, Hypodermic, Single Lumen111
JKATubes, vials, systems, serum separators, blood collection91
OFMPhlebotomy blood collection kit62
FPASet, administration, intravascular54

GMDN & GCC registration

  • GMDN code 58497 · non‑implantable
  • Single‑use 100% · sterile 92% · Rx‑only 76% · 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) · 111Length (Inch) · 45Weight (Gram) · 18Height (Inch) · 15Width (Inch) · 14Length (Millimeter) · 14

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

How many blood collection set, invasive products are registered in the US?

631 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood collection set, invasive", from 54 companies. The largest labeler is Jiangsu Caina Medical Co.,Ltd with 7% of records.

Which FDA product codes apply?

JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), FPA (Set, Administration, Intravascular), 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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