Identity
- Trade Name
- Mallinckrodt FDA UDI
- Generic Name
- Endobronchial tube FDA UDI
- Device Name
- Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube; Endobronchial Tube Accessories,Left,(2) Right Angle Swivel Connectors; Carlens Y Adapter FDA UDI
- Model / Reference
- 125037 FDA UDI
- Description
- Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube; Endobronchial Tube Accessories,Left,(2) Right Angle Swivel Connectors; Carlens Y Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30884522008741 FDA UDI
- 510(k) Number
- K771219 FDA UDI
- FDA Product Code
- BTS FDA UDI
- GMDN Term
- Endobronchial tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5720 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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 37 French FDA UDI
Category: Endobronchial tube
Mallinckrodt by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endobronchial tube.
- RUSCH — TELEFLEX INCORPORATED · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Human-broncho endobronchial tube — INSUNG MEDICAL Co., Ltd.. · Class II
- Parker Flex-Tip — SALTER LABS · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Endobronchial Tube — Well Lead Medical Co., Ltd · Class II
- SILBRONCHO (RIGHT LUNG) — Fuji Systems Corp. · Class II
Cleared under the same submission
K771219 also covers:
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
- Mallinckrodt — Covidien LP
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
- Covidien LP
Sources (1)
- FDA UDI 372d08e3-6c34-4f32-bf97-5673b81f4f6d 37 fields · synced May 30, 2026