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VentiSeal Reinforced ET Tube ID 8.5 + Stylet - Sterile
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- VentiSeal Reinforced ET Tube ID 8.5 + Stylet - Sterile FDA UDI
- Generic Name
- Reinforced endotracheal tube, single-use FDA UDI
- Model / Reference
- 038-980-085U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788707684 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Reinforced 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: Reinforced endotracheal tube, single-use
VentiSeal Reinforced ET Tube ID 8.5 + Stylet - Sterile by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
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- cuff — Contec Medical Systems Co., Ltd. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
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- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · 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 839ff99c-1f28-43c2-bbcf-b4b22f5a8eff 32 fields · synced May 29, 2026