AccessGUDID - DEVICE: HemosIL Factor V Reagent Plasma (for APC R V) (08426950087656)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Factor V Reagent Plasma (for APC R V)
Version or Model: 00020008800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00020008800
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950087656
Issuing Agency: GS1
Commercial Distribution End Date: December 29, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Factor V Reagent Plasma (for APC R V)

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):	Yes
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?
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGW	TEST, TIME, PARTIAL THROMBOPLASTIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963111	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Unopened reagent is stable until the expiration date shown on the vial when stored at 2-8°C.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c1b2ba1-d1bf-4188-b0b3-916aa2e76fda
Public Version Date: January 01, 2024
Public Version Number: 9
DI Record Publish Date: September 23, 2016