Identity
- Trade Name
- Unimed FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- 'Disposable Blood Pressure Transducer Edwards FDA UDI
- Model / Reference
- DP-ED FDA UDI
- Description
- 'Disposable Blood Pressure Transducer Edwards FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936735471935 FDA UDI
- 510(k) Number
- K152472 FDA UDI
- FDA Product Code
- DRS FDA UDI
- GMDN Term
- Invasive-pressure external transducer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Invasive-pressure external transducer, single-use
Unimed by Unimed Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Invasive-pressure external transducer, single-use.
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- TRUWAVE, VAMP — Edwards Lifesciences LLC · Class II
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- TRUWAVE — Edwards Lifesciences LLC · Class II
- Medex — ICU MEDICAL, INC. · Class II
- TRUWAVE/VAMP — Edwards Lifesciences LLC · Class II
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC · Class II
- TRUWAVE, VAMP — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K152472 also covers:
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, 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
- Unimed Medical Supplies, Inc.
Sources (1)
- FDA UDI 045d0624-e94a-4d3b-9ca2-52e1b503eee5 34 fields · synced May 30, 2026