Identity
- Trade Name
- SP 840 - 32021 FDA UDI
- Generic Name
- Invasive-pressure external transducer, reusable FDA UDI
- Model / Reference
- 0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07071977000075 FDA UDI
- 510(k) Number
- K792020 FDA UDI
- FDA Product Code
- DRS FDA UDI
- GMDN Term
- Invasive-pressure external transducer, reusable 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive-pressure external transducer, reusable
Sp 840 - 32021 by Memscap AS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Invasive-pressure external transducer, reusable.
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- Medex — ICU MEDICAL, INC. · Class II
- Medex — ICU MEDICAL, INC. · Class II
- Medex — ICU MEDICAL, INC. · Class II
- Medex — ICU MEDICAL, INC. · Class II
- Medex — ICU MEDICAL, INC. · Class II
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Cleared under the same submission
K792020 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
- Memscap AS
Sources (1)
- FDA UDI 06c66755-6d82-47fa-92d0-5afd17bac9c1 33 fields · synced May 30, 2026