AccessGUDID - DEVICE: PremierPro Lancet (00811220030353)

GUDID

Device Identifier (DI) Information

Brand Name: PremierPro Lancet
Version or Model: 7551
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7551
Company Name: SVS LLC

Primary DI Number: 00811220030353
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831375089 *Terms of Use

Device Description: Color: Pink Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.

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":	Yes
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?
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
FMK	Lancet, Blood

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
Device Size Text, specify: 21G Needle x 2.0 mm Depth

Device Record Status

Public Device Record Key: 19758ccf-32e9-4c87-8a07-323dfe432f3b
Public Version Date: November 21, 2022
Public Version Number: 3
DI Record Publish Date: August 03, 2018