AccessGUDID - DEVICE: MEDLINE INDUSTRIES, INC. (10888277365940)

GUDID

Device Identifier (DI) Information

Brand Name: MEDLINE INDUSTRIES, INC.
Version or Model: MPH3550FL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPH3550FL
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10888277365940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: STRIP, GLUCOSE, FOIL, G3, PROF.USE ONLY

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):	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?
42391	Capillary thermometer cover	A device intended to be used as a physical barrier for an alcohol or mercury capillary thermometer to prevent cross-contamination between patients and/or environmental exposure. This is a single-use device.	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 [?]
K120448	000

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
Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight. Protect from freezing, avoid excessive heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d489694-e7f4-4b07-be28-506307a6a487
Public Version Date: October 11, 2021
Public Version Number: 1
DI Record Publish Date: October 01, 2021