Consulting Wallah › Device Explorer › IVD & laboratory › Non-evacuated blood collection tube IVD, no additi
Device Explorer · FDA GUDID · GMDN 37563

Non-evacuated blood collection tube IVD, no additive

A non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

US‑registered devices64in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Cardinal Health, Inc.4062%
Cardinal Health 200, Llc1422%
Sarstedt Aktiengesellschaft & Co.Kg1016%

Top labelers

CompanyDevicesShare
Cardinal Health, Inc.4062%
Cardinal Health 200, Llc1422%
Sarstedt Aktiengesellschaft & Co.Kg1016%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

S-Monovette® 2.7mlS-Monovette®MonojectCorvacCovidien

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

FDA product codes

CodeNameDevices
GIMTubes, vacuum sample, with anticoagulant77
JKATubes, Vials, Systems, Serum Separators, Blood Collection9
JKATubes, vials, systems, serum separators, blood collection3

GMDN & GCC registration

  • GMDN code 37563 · non‑implantable
  • Single‑use 100% · sterile 98% · Rx‑only 83% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 45Outer Diameter (Millimeter) · 45Length (Millimeter) · 45

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

How many non-evacuated blood collection tube ivd, no additive products are registered in the US?

64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-evacuated blood collection tube IVD, no additive", from 3 companies. The largest labeler is Cardinal Health, Inc. with 62% of records.

Which FDA product codes apply?

GIM (Tubes, vacuum sample, with anticoagulant), JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), 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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