AccessGUDID - DEVICE: MICROLET® (00301936586218)

GUDID

Device Identifier (DI) Information

Brand Name: MICROLET®
Version or Model: 6586 / 6586W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81264857, 81264954 (US)
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 00301936586218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.

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:	Yes
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?
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use 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 [?]
K220633	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not use if protective cap has been previously removed. Do not reuse.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55dfab27-fce9-4952-97fc-e7516661e22c
Public Version Date: November 22, 2022
Public Version Number: 2
DI Record Publish Date: June 06, 2019