AccessGUDID - DEVICE: Quality Choice Autolet (00635515959347)

GUDID

Device Identifier (DI) Information

Brand Name: Quality Choice Autolet
Version or Model: AT 0274QC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHAIN DRUG MARKETING ASSOCIATION, INC.

Primary DI Number: 00635515959347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011920774 *Terms of Use

Device Description: Quality Choice Autolet Lancing Device

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
QRL	Multiple Use Blood Lancet For Single Patient Use Only

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: adb4af16-8ab6-4ad1-9b52-3433ef95e308
Public Version Date: February 13, 2023
Public Version Number: 1
DI Record Publish Date: February 03, 2023