Identity
- Trade Name
- Parker Flex-Tip FDA UDI
- Generic Name
- Basic endotracheal tube, single-use FDA UDI
- Device Name
- Endotracheal Tube, Uncuffed (PFUO), Parker, 8.0mm FDA UDI
- Model / Reference
- H-PFUO-80 FDA UDI
- Description
- Endotracheal Tube, Uncuffed (PFUO), Parker, 8.0mm FDA UDI
Identifiers
- Catalog Number
- H-PFUO-80 FDA UDI
- Primary DI / UDI-DI
- 10749065021809 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 8.0 Millimeter FDA UDI
Category: Basic endotracheal tube, single-use
Parker Flex-Tip by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic endotracheal tube, single-use.
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- 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
- Salter Labs
Sources (1)
- FDA UDI 2b738fc5-60d0-4952-aafc-bf7fb9936513 37 fields · synced May 30, 2026