Identity
- Trade Name
- Filter CareStar 20 Plus FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Model / Reference
- MP05770 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675665748 FDA UDI
- 510(k) Number
- K221836 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Microbial medical gas filter, 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: Microbial medical gas filter, single-use
Filter CareStar 20 Plus by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Microbial medical gas filter, single-use.
- ECO slimline — GVS Filter Technology UK Ltd · Class IIa
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Ventlab — Ventlab Corp. · Class II
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- Ventlab — Ventlab Corp. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K221836 also covers:
- CombiStar Plus Filter + HME HEPA flex — Drägerwerk AG & Co. KGaA
- 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 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI f7742c77-656a-4f9a-b076-dab691b4820b 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026