AccessGUDID - DEVICE: HemosIL Factor X Deficient Plasma (10 X 1 mL) (08426950491385)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Factor X Deficient Plasma (10 X 1 mL)
Version or Model: 00020010000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020010000
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950491385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Factor X Deficient Plasma (10 X 1 mL)

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?
56034	Coagulation factor X IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor X in a clinical specimen, using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJT	PLASMA, COAGULATION FACTOR DEFICIENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031122	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
Special Storage Condition, Specify: Unopened deficient plasma is stable until the expiration date shown on the vial when stored at 2-8°C.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50c20abf-ac69-4e95-b55a-96b68cdf65bd
Public Version Date: July 14, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016