AccessGUDID - DEVICE: STAT Medical Devices (00709334883883)

GUDID

Device Identifier (DI) Information

Brand Name: STAT Medical Devices
Version or Model: Qwik-Lance Safety Lancet
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RQL-100
Company Name: Stat Medical Devices, Inc.

Primary DI Number: 00709334883883
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967687286 *Terms of Use

Device Description: The Disposable Safety Lancet is intended for capillary blood sampling.

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):	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?
61578	Manual blood lancing device, single-use	A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded 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 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 [?]
K222408	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18b08ebb-e246-4b8e-97cd-a4253a3cb55e
Public Version Date: December 06, 2023
Public Version Number: 1
DI Record Publish Date: November 28, 2023