Identity
- Trade Name
- Cough Assist Kit FDA UDI
- Generic Name
- Respirator filter/cartridge, particulates FDA UDI
- Device Name
- Cough Assist Kit - This kit contains: (1) RES013, (1) BF2200, (1) TUB004 FDA UDI
- Model / Reference
- CAKIT001B FDA UDI
- Description
- Cough Assist Kit - This kit contains: (1) RES013, (1) BF2200, (1) TUB004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530105440 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Respirator filter/cartridge, particulates FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Respirator filter/cartridge, particulates
Cough Assist Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respirator filter/cartridge, particulates.
- Portable Negative Pressure Vacuum — Robrady Inc · Class II
- Respiratory Shield — Robrady Inc · Class I
- SafetyFilta — GROMAN INC. · Class I
- EndoShield — Robrady Inc · Class I
- 6IN HEPA Capsule with Removable Sticker — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Bacteria Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Bacteria Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI c6b0d111-f583-42f6-abe1-e5e497dfaaf8 34 fields · synced May 29, 2026