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ProVu Video Stylet Reusable 2m Amplifier Cable
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 038-990-012U
Identity
- Trade Name
- ProVu Video Stylet Reusable 2m Amplifier Cable FDA UDI
- Generic Name
- Artificial airway stylet, single-use FDA UDI
- Device Name
- Video Display Accessories EUDAMED
- Model / Reference
- 038-990-012U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788782506 EUDAMEDFDA UDI
- Basic UDI-DI
- 5055788700015501H7 EUDAMED
- FDA Product Code
- BSR FDA UDI
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Artificial airway stylet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5790 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Artificial airway stylet, single-use
ProVu Video Stylet Reusable 2m Amplifier Cable by Flexicare Medical Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Artificial airway stylet, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI d0a322e6-fb08-4bef-8fc5-bd85b3a02ccb 32 fields · synced Jul 17, 2026
- EUDAMED a7bc9cca-b169-4430-8eb5-31980e4cc36a 61 fields · synced Jul 17, 2026