Identity
- Trade Name
- CombiStar Plus Filter + HME HEPA flex FDA UDI
- Generic Name
- Breathing circuit catheter mount, single-use FDA UDI
- Model / Reference
- MP12062 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675714422 FDA UDI
- 510(k) Number
- K221836 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Breathing circuit catheter mount, single-use 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
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
MR Unsafe FDA UDI
Category: Breathing circuit catheter mount, single-use
CombiStar Plus Filter + HME HEPA flex by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221836 also covers:
- CombiStar Plus Filter + HME flex — Drägerwerk AG & Co. KGaA
- CombiStar Plus Filter + HME straight — Drägerwerk AG & Co. KGaA
- CombiStar Plus Filter flex — Drägerwerk AG & Co. KGaA
- Filter CareStar 20 Plus — Drägerwerk AG & Co. KGaA
- Filter CareStar 35 Plus — Drägerwerk AG & Co. KGaA
- Filter SafeStar 55 Plus — Drägerwerk AG & Co. KGaA
- Filter SafeStar 60A Plus — Drägerwerk AG & Co. KGaA
- Filter SafeStar 90 Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 25 Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 55 Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 60A Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 9 Plus — Drägerwerk AG & Co. KGaA
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
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 9550e7d6-32ee-44ac-8ef9-df9404183a1c 33 fields · synced May 31, 2026