AccessGUDID - DEVICE: Calibration Plasma LMW Heparin (08426950088974)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Plasma LMW Heparin
Version or Model: 82 3500 63
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82 3500 63
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950088974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: Calibration Plasma LMW Heparin

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:	Yes
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?
56196	Heparin anti-Xa IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	CALIBRATOR, PRIMARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030964	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 calibrators are 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: a203ef98-3d46-40ca-a92b-554d2708e2fa
Public Version Date: July 13, 2021
Public Version Number: 6
DI Record Publish Date: September 23, 2016