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VentiSeal HVLP Cuffed Oral/Nasal ET Tube ID Size 7.0mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- VentiSeal HVLP Cuffed Oral/Nasal ET Tube ID Size 7.0mm FDA UDI
- Generic Name
- Basic endotracheal tube, single-use FDA UDI
- Model / Reference
- 038-971-070VDOU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788705130 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Basic endotracheal tube, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 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
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
No
FDA UDI
Category: Basic endotracheal tube, single-use
VentiSeal HVLP Cuffed Oral/Nasal ET Tube ID Size 7.0mm by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Basic endotracheal tube, single-use.
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- Endotracheal Tubes — Dynarex Corp. · Class II
- ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 3 — Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) · Class IIa
- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
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
- Flexicare Medical Limited
Sources (1)
- FDA UDI 445fac37-4181-4ba2-9f90-6cd9fad77b86 32 fields · synced May 31, 2026