FDA UDI
In Commercial Distribution
🇺🇸 United States
Tempo Welcome Kit
DI: 00300020948550
·
Model: MS9841
·
ELI LILLY AND COMPANY
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tempo Welcome Kit
- Primary DI
- 00300020948550
- Version / Model
- MS9841
- Catalog Number
- MS9841001AM
- Company Name
- ELI LILLY AND COMPANY
- Labeler DUNS
- 006421325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-01
- Public Version
- 1
- Public Version Date
- 2022-11-09
- Public Version Status
- New
- Public Device Record Key
- 401c04bf-c3ce-439a-a946-0248a8a1b357
Device Description
Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
| OCN | Insulin Autoantibody Kit | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30300020948551 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00300020948550 | GS1 |
Customer Contacts
- Phone
- 1-855-545-5983
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212217 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 34 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity