Identity
- Trade Name
- SunMed FDA UDI
- Generic Name
- Artificial airway cuff inflation tubing FDA UDI
- Device Name
- CUFF INFLATION BULB FDA UDI
- Model / Reference
- 4-0101-00 FDA UDI
- Description
- CUFF INFLATION BULB FDA UDI
Identifiers
- Catalog Number
- 4-0101-00 FDA UDI
- Primary DI / UDI-DI
- 10889483002599 FDA UDI
- 510(k) Number
- K102674 FDA UDI
- FDA Product Code
- BSK FDA UDI
- GMDN Term
- Artificial airway cuff inflation tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Artificial airway cuff inflation tubing
SunMed by SunMed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial airway cuff inflation tubing.
- TRACOE technic — Tracoe medical GmbH · Class II
- Oxygen Connector — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Oxygen Connector/Adapter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Oxygen Accessories — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Ventilator Circuit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
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
- SunMed
Sources (1)
- FDA UDI 5f451ddc-4b84-4f55-a603-a354dbe64b10 36 fields · synced May 30, 2026