AccessGUDID - DEVICE: HemosIL SynthASil (08426950078920)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL SynthASil
Version or Model: 00020006800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020006800
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950078920
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL SynthASil

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?
55981	Activated partial thromboplastin time (APTT) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFO	ACTIVATED PARTIAL THROMBOPLASTIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060688	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 reagents are 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: 3173ce60-ca54-458a-8dd7-da4b183a3513
Public Version Date: July 13, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016