AccessGUDID - DEVICE: PIP (00732671009357)

GUDID

Device Identifier (DI) Information

Brand Name: PIP
Version or Model: 935
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 935
Company Name: AMITY HOLDINGS, LLC

Primary DI Number: 00732671009357
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 016069284 *Terms of Use

Device Description: Lancing Device with Ejector

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
FMK	Lancet, Blood

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 41ee9600-fb7d-492a-b321-f9a8b98a1131
Public Version Date: April 11, 2022
Public Version Number: 2
DI Record Publish Date: December 30, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10732671109351	1	00732671009357	2025-12-30	In Commercial Distribution	Chipboard Box
20732671209355	100	10732671109351	2025-12-30	In Commercial Distribution	Corrugate Carton
30732671309359	400	20732671209355	2025-12-30	In Commercial Distribution	Corrugate Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800 327 8894
Email: wconety@medicore.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES