Tris Buffered Saline 100991

GUDID G0561009910

Bio/Data Corporation

Buffered isotonic saline reagent IVD
Primary Device IDG0561009910
NIH Device Record Keyfd4b828a-403f-4164-ba60-b6e786a2199a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTris Buffered Saline
Version Model Number100991
Catalog Number100991
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
HIBCCG0561009910 [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
G0561009910 - Tris Buffered Saline2023-09-07
G0561009940 - Sodium Citrate2023-09-07
G0561013751 - Profiler Paper2023-09-07
G0561015211 - Test Tubes, Micro2023-09-07
G0561055981 - Printer Paper2023-09-07

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