AccessGUDID - DEVICE: AboutTime MPD 28G x 1.8mm Safety Lancet (00628465014563)

GUDID

Device Identifier (DI) Information

Brand Name: AboutTime MPD 28G x 1.8mm Safety Lancet
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1456
Company Name: Medical Plastic Devices M.P.D. Inc

Primary DI Number: 00628465014563
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 244897773 *Terms of Use

Device Description: 28G x 1.8mm MPD Safety Lancet Box of 100 Single use Sterile Safe Needle is fully shielded before and after use Sterilized by gamma irradiation Comfortable High Quality Tri-bevel point with high speed penetration Tri-Bevel tip ensures good blood flow Optimal ergonomic design Convenient Pre-loaded and pressure activated device Less pressure power.

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?
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	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: 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: eaf494f1-e802-4aaf-a79d-f999452f9ee6
Public Version Date: March 04, 2020
Public Version Number: 1
DI Record Publish Date: February 25, 2020