Identity
- Trade Name
- Parker FDA UDI
- Generic Name
- Artificial airway stylet, single-use FDA UDI
- Device Name
- Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 41 Fr, O.D 12.0mm, I.D 5.0mm Parker Original DID: 10749065061508 . FDA UDI
- Model / Reference
- H-PFTDL-41 FDA UDI
- Description
- Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 41 Fr, O.D 12.0mm, I.D 5.0mm Parker Original DID: 10749065061508 . FDA UDI
Identifiers
- Catalog Number
- H-PFTDL-41 FDA UDI
- Primary DI / UDI-DI
- 00607411959387 FDA UDI
- 510(k) Number
- K092886 FDA UDI
- FDA Product Code
- CBI FDA UDI
- GMDN Term
- Artificial airway stylet, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5740 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
Category: Artificial airway stylet, single-use
Parker by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092886 also covers:
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salter Labs
Sources (1)
- FDA UDI de5c6592-0727-40c7-acaf-54c1d365153f 36 fields · synced May 30, 2026