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Device Explorer · FDA GUDID · GMDN 58496

Blood collection set, noninvasive

A collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood sp

US‑registered devices112in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile86%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Medline Industries, Inc.7971%
Regenlab Usa Llc1211%
Hartman Medical Group Llc44%
Centurion Medical Products Corporation44%
Sb-Kawasumi Laboratories, Inc.33%
Magnolia Medical Technologies, Inc.22%
Avia Vascular, Llc22%
Intra-Lock International, Inc.22%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.7971%
Regenlab Usa Llc1211%
Hartman Medical Group Llc44%
Centurion Medical Products Corporation44%
Sb-Kawasumi Laboratories, Inc.33%
Magnolia Medical Technologies, Inc.22%
Avia Vascular, Llc22%
Intra-Lock International, Inc.22%
Bound Tree Medical, Llc22%
Bioreference Health, Llc11%
Innovative Medical Technologies, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rapid Access Kawasumi Multiple Sample Adapter wiRapid Transfer Kawasumi Multiple Sample Adapter Steripath MicroSteriPath Gen2, Luer, TS22G Open-System Ally Blood Collection Device20G Open-System Ally Blood Collection Device4Kscore TestCellular MembraneRegenKit-ATS-3-URegenKit-ATS-T-UEnhanced HARegenLab USARegenKit Wound-GelIntra-LockCuraplexULTRAFLO-A

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)73
JKATubes, Vials, Systems, Serum Separators, Blood Collection11
PMQPeripheral Blood Processing Device For Wound Management4
LROGeneral Surgery Tray4
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)3
LROGeneral surgery tray3

GMDN & GCC registration

  • GMDN code 58496 · non‑implantable
  • Single‑use 100% · sterile 86% · Rx‑only 90% · 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

Outer Diameter (Inch) · 2

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

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

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood collection set, noninvasive", from 11 companies. The largest labeler is Medline Industries, Inc. with 71% of records.

Which FDA product codes apply?

OIB (Blood and urine collection kit (excludes HIV testing)), JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), PMQ (Peripheral Blood Processing Device For Wound Management), LRO (General Surgery Tray)

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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