AccessGUDID - DEVICE: CareLiving Push Button Activated Safety lancet 28G (00383568100239)

GUDID

Device Identifier (DI) Information

Brand Name: CareLiving Push Button Activated Safety lancet 28G
Version or Model: Push Button Activated Safety Lancet 28
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83568-1002-39
Company Name: Care Living Diagnostics Inc.

Primary DI Number: 00383568100239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 125354643 *Terms of Use

Device Description: Push Button Activated Safety lancet 28G*1.6mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and low puncture force provide users an almost painless experience of blood sampling.The Lancet is used for perpheral blood collection when clinical examination.

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:	Yes
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?
61579	Blood lancet, single-use	A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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: Yes
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
Needle Gauge: 28 Gauge

Device Record Status

Public Device Record Key: ae87e67b-79ad-4036-9764-9b5b30993d4a
Public Version Date: February 02, 2024
Public Version Number: 1
DI Record Publish Date: January 25, 2024