Identity
- Trade Name
- NAMIC FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- Perceptor DT Standard Pole Mount Kit FDA UDI
- Model / Reference
- 70400055 FDA UDI
- Description
- Perceptor DT Standard Pole Mount Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- H965704000550 FDA UDI
- 510(k) Number
- K910764 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 24 Inch FDA UDI
Category: Invasive-pressure external transducer, single-use
Namic by Navilyst Medical, 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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Cleared under the same submission
K910764 also covers:
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, 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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI 3304ea1e-1758-4660-a43f-b0ee87bb0212 36 fields · synced May 30, 2026