Identity
- Trade Name
- Tempo FDA UDI
- Generic Name
- Blood lancing device tip FDA UDI
- Device Name
- Tempo lancet (100T/pack) FDA UDI
- Model / Reference
- PGUHA-0000033 FDA UDI
- Description
- Tempo lancet (100T/pack) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810011730045 FDA UDI
- 510(k) Number
- K220475 FDA UDI
- FDA Product Code
- QRK FDA UDI
- GMDN Term
- Blood lancing device tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood lancing device tip
Tempo by i-SENS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood lancing device tip.
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- H.E.B. inControl — H. E. BUTT GROCERY COMPANY · Class II
- Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
Cleared under the same submission
K220475 also covers:
- TechLITE® Lancets, 26g — ARKRAY USA, INC.
- TechLITE® Lancets, 28g — ARKRAY USA, INC.
- Greater Goods — Greater Goods, LLC
- Pylo Health — PREVOUNCE HEALTH, INC
- Pylo Health — PREVOUNCE HEALTH, INC
- GLUCOPAD TC-SMART+ Lancets Kit — TECO DIAGNOSTICS
- CareSens — i-SENS, Inc.
- CareSens — i-SENS, Inc.
- CareSens — i-SENS, Inc.
- Tempo — i-SENS, Inc.
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
- i-SENS, Inc.
Sources (1)
- FDA UDI ae86343b-6aff-4dd4-9a16-c1774c69c18d 34 fields · synced Jun 8, 2026