AccessGUDID - DEVICE: ADVOCATE Lancing Device Red Dot (00852982006002)

GUDID

Device Identifier (DI) Information

Brand Name: ADVOCATE Lancing Device Red Dot
Version or Model: 329
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 329
Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.

Primary DI Number: 00852982006002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043081723 *Terms of Use

Device Description: Advocate Lancing Device Red Dot, ergonomically designed, safety switch feature locks the trigger when uncapped, 6 depth adjustment, safer, easier lancet ejection

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):	No
Over the Counter (OTC):	Yes
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?
37243	Manual blood lancing device, reusable	A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Lancet, Blood

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: 3a14fbd7-fc98-4ee6-88a0-2adac2899359
Public Version Date: July 21, 2020
Public Version Number: 2
DI Record Publish Date: June 22, 2020