Tempo Welcome Kit

FDA UDI

Class II (US FDA UDI)

by Eli Lilly And Company

Identity

Trade Name: Tempo Welcome Kit FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles. FDA UDI
Model / Reference: MS9841 FDA UDI
Description: Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles. FDA UDI

Identifiers

Catalog Number: MS9841001AM FDA UDI
Primary DI / UDI-DI: 00300020948550 FDA UDI
510(k) Number: K212217 FDA UDI
FDA Product Code: NBW FDA UDI
FMK FDA UDI
FMI FDA UDI
OCN FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
878.4850 FDA UDI
880.5570 FDA UDI
866.5660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Glucose monitoring system IVD, home-use

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

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CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
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Cleared under the same submission

K212217 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Eli Lilly And Company

Sources (1)

FDA UDI 401c04bf-c3ce-439a-a946-0248a8a1b357 37 fields · synced Jun 8, 2026