BloodGas Monovette®2ml 05.1147.120

GUDID 04066916037543

Sarstedt Aktiengesellschaft & Co.KG

Non-evacuated blood collection tube IVD, anticoagulant
Primary Device ID04066916037543
NIH Device Record Key48f581c4-8ec2-4c88-a21b-a57a5080c8ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameBloodGas Monovette®2ml
Version Model Number05.1147.120
Catalog Number05.1147.120
Company DUNS388000270
Company NameSarstedt Aktiengesellschaft & Co.KG
Device Count150
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104066916037543 [Unit of Use]
GS104066916037550 [Primary]

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

Devices Manufactured by Sarstedt Aktiengesellschaft & Co.KG

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04066916037581 - BloodGas Monovette®2ml Adapter2025-07-10
04066916039806 - BloodGas Monovette®2ml Ventilat2025-07-10
04066916040338 - Monovette® 1ml LH2025-07-10
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04038917530606 - Safety-Needle 23Gx1"2025-05-12
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