AccessGUDID - DEVICE: THE EDGE Blood Lactate Monitoring System (04713648766530)

GUDID

Device Identifier (DI) Information

Brand Name: THE EDGE Blood Lactate Monitoring System
Version or Model: The EDGE meter
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APEX BIOTECHNOLOGY CORP.

Primary DI Number: 04713648766530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657608092 *Terms of Use

Device Description: KIT

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
Prescription Use (Rx):	No
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?
35885	Lactate monitoring system IVD, home-use	A collection of devices including a dedicated, portable, electrically-powered instrument (self-testing meter) reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of lactate in a whole blood specimen.; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is typically used to monitor physical performance and conditioning in sport, and/or to support patient management.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHP	Acid, Lactic, Enzymatic Method

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc11fddc-dd0d-4a45-b23f-871995c0a594
Public Version Date: January 26, 2021
Public Version Number: 1
DI Record Publish Date: January 18, 2021