Sodium Citrate 100994

GUDID G0561009940

Bio/Data Corporation

Saline sodium citrate buffer IVD
Primary Device IDG0561009940
NIH Device Record Key53d40fe0-5b16-489e-adb0-6c0b473f3002
Commercial Distribution StatusIn Commercial Distribution
Brand NameSodium Citrate
Version Model Number100994
Catalog Number100994
Company DUNS051392959
Company NameBio/Data Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG0561009940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASystem, Multipurpose For In Vitro Coagulation Studies

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

Devices Manufactured by Bio/Data Corporation

G0561076501 - AGG/PAK 5 Combo Kit2024-10-09
G0561003361 - Test Tubes, Macro2023-09-07
G0561009890 - Calcium Chloride2023-09-07
G0561009910 - Tris Buffered Saline2023-09-07
G0561009940 - Sodium Citrate2023-09-07
G0561009940 - Sodium Citrate2023-09-07
G0561013751 - Profiler Paper2023-09-07
G0561015211 - Test Tubes, Micro2023-09-07
G0561055981 - Printer Paper2023-09-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.