AccessGUDID - DEVICE: Dade® Owren's Veronal Buffer (00842768003981)

GUDID

Device Identifier (DI) Information

Brand Name: Dade® Owren's Veronal Buffer
Version or Model: 10445724
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B4234-25
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768003981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Dilution buffer for coagulation testing

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	Active	false

[?]

FDA Product Code

Product Code	Product Code Name
KQJ	SYSTEM, FIBRINOGEN DETERMINATION

[?]

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050928	000

Sterilization

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

[?]

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Customer Contact

[?]

DEVICE: Dade® Owren's Veronal Buffer (00842768003981)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact