AccessGUDID - DEVICE: Tempo Refill Kit (00300021151553)

GUDID

Device Identifier (DI) Information

Brand Name: Tempo Refill Kit
Version or Model: MC0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC0002001AM
Company Name: ELI LILLY AND COMPANY

Primary DI Number: 00300021151553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006421325 *Terms of Use

Device Description: Tempo Refill Kit - This is a convenience kit which contains multiple devices with different counts: Lancets/Strips/BD needles and gauze pads.

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:	Yes
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?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
FMI	Needle, Hypodermic, Single Lumen
OCN	Insulin Autoantibody Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212217	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 34 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd2d5795-9b78-478d-aef1-e1f5015cc2f4
Public Version Date: September 05, 2023
Public Version Number: 1
DI Record Publish Date: August 28, 2023