Identity
- Trade Name
- Tempo FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Tempo Premium Sphygmomanometer with Adult Cuff FDA UDI
- Model / Reference
- AS3053 FDA UDI
- Description
- Tempo Premium Sphygmomanometer with Adult Cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857425005970 FDA UDI
- 510(k) Number
- K193259 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aneroid manual sphygmomanometer
Tempo by Hemasource — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aneroid manual sphygmomanometer.
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- e-mega® black, disinfectable one-piece cuff, small adult size 2-tube — Rudolf Riester GmbH & Co. KG · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Princess — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- E-sphyg™ — American Diagnostic Corporation · Class II
- BAUM — W.A. BAUM CO., INC. · Class II
Cleared under the same submission
K193259 also covers:
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- GAHAM FIELD — GF Health Products, Inc
- GRAHAM FIELD — GF Health Products, Inc
- GRAHAM FIELD — GF Health Products, Inc
- GRAHAM FIELD — GF Health Products, Inc
- RITE AID — MICROLIFE USA, INC.
- HealthMart — STRATEGIC SOURCING SERVICES LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemasource
Sources (1)
- FDA UDI e90bd330-2b7d-4d30-8afb-bd2f00f7c03a 34 fields · synced Jun 6, 2026