AccessGUDID - DEVICE: AIMSTRIP PLUS LANCETS (00695684373115)

GUDID

Device Identifier (DI) Information

Brand Name: AIMSTRIP PLUS LANCETS
Version or Model: 37311
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GERMAINE LABORATORIES, INC

Primary DI Number: 00695684373115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 176458115 *Terms of Use

Device Description: Lancets (sterile) for use with Blood Glucose Test Strips & meter for testing blood glucose levels

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):	Yes
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?
60740	Home-use blood glucose spot-check system	An electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

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: 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: 62bdc17c-93cf-4d23-ac64-15ee08b968dd
Public Version Date: September 09, 2020
Public Version Number: 3
DI Record Publish Date: April 27, 2016