AccessGUDID - DEVICE: Tempo Smart Button (00300020911554)

GUDID

Device Identifier (DI) Information

Brand Name: Tempo Smart Button
Version or Model: MS6303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MS6303
Company Name: ELI LILLY AND COMPANY

Primary DI Number: 00300020911554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006421325 *Terms of Use

Device Description: Reusable connected data transfer module.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
37324	Patient monitoring system module, data memory	A small unit that serves as a temporary store of data; typically patient related data given from other devices, e.g., patient monitors or analysers which are not connected to a network, or are in a transport phase. This data is stored in this module's memory for transfer to a permanent store, e.g., the patient's electronic journal. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOG	Injection Data Capture Device

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
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d22d4ec8-b8f0-4658-ba70-c7fbde2bacd5
Public Version Date: November 09, 2022
Public Version Number: 1
DI Record Publish Date: November 01, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30300020911555	1	00300020911554		In Commercial Distribution	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: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18555455983
Email: xxx@xxx.xxx

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