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Tempo Smart Button

FDA UDI

Class II (US FDA UDI)

by Eli Lilly And Company

Identity

Trade Name
Tempo Smart Button FDA UDI
Generic Name
Patient monitoring system module, data memory FDA UDI
Device Name
Reusable connected data transfer module. FDA UDI
Model / Reference
MS6303 FDA UDI
Description
Reusable connected data transfer module. FDA UDI

Identifiers

Catalog Number
MS6303 FDA UDI
Primary DI / UDI-DI
00300020911554 FDA UDI
510(k) Number
K212217 FDA UDI
FDA Product Code
QOG FDA UDI
GMDN Term
Patient monitoring system module, data memory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Patient monitoring system module, data memory

Tempo Smart Button by Eli Lilly And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, data memory.

Cleared under the same submission

K212217 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eli Lilly And Company

Sources (1)

  • FDA UDI d22d4ec8-b8f0-4658-ba70-c7fbde2bacd5 37 fields · synced May 30, 2026