Consulting Wallah › Device Explorer › IVD & laboratory › Non-evacuated blood collection tube IVD, anticoagu
Device Explorer · FDA GUDID · GMDN 58144

Non-evacuated blood collection tube IVD, anticoagulant

A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), lithium heparin, sodium citrate]. It is intended to be used for the collection, and preservation and/or transport, of blood

US‑registered devices91in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile74%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Sarstedt Aktiengesellschaft & Co.Kg8796%
Becton, Dickinson And Company22%
Greiner Bio-One Gmbh22%

Top labelers

CompanyDevicesShare
Sarstedt Aktiengesellschaft & Co.Kg8796%
Becton, Dickinson And Company22%
Greiner Bio-One Gmbh22%

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

Brand names on the register (sample)

Monovette® 1ml LHBloodGas Monovette®2ml VentilatBloodGas Monovette®2ml AdapterBloodGas Monovette®2mlTube 4 ml, 75 x 12 mm, K3ES-Monovette® 1.6ml LH1,6ml S-Monov. LiI-HEPS-Monovette® 7.5ml K3ES-Monovette® 2,7 ml EDTA PinkMicro tube 1ml 9NCMicro tube 1.3ml LHMicro tube 1.3ml K3ES-Monovette®S-Monovette® 1.6ml K3EMicro tube 1.3ml K3E MembraneMicro tube 0.5ml 9NC

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 Collection61
PPMGeneral purpose reagent25
JKATubes, vials, systems, serum separators, blood collection18
PPMGeneral Purpose Reagent1

GMDN & GCC registration

  • GMDN code 58144 · non‑implantable
  • Single‑use 100% · sterile 74% · Rx‑only 4% · OTC 0%
  • 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 (Microliter) · 7

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

How many non-evacuated blood collection tube ivd, anticoagulant products are registered in the US?

91 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, anticoagulant", from 3 companies. The largest labeler is Sarstedt Aktiengesellschaft & Co.Kg with 96% of records.

Which FDA product codes apply?

JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), PPM (General purpose reagent), JKA (Tubes, vials, systems, serum separators, blood collection), PPM (General Purpose Reagent)

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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