AccessGUDID - DEVICE: HemosIL Rinse Solution (ACLFutura Advance) (08426950553502)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Rinse Solution (ACLFutura Advance)
Version or Model: 00020302500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00020302500
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950553502
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Rinse Solution 2L (ACLFutura Advance)

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?
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21422238-924f-4d13-b6f0-0526ea2bb608
Public Version Date: July 09, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016