Medline HCS64184
Medline HCS64184 is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K023683 on 1 Dec 2003 and listed in FDA GUDID since 5 Nov 2020 (UDI-DI 10884389121269), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884389121269 | Date5 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023683 | Date1 Dec 2003 | StatusActive |
Official records
- AccessGUDID record 10884389121269
- FDA 510(k) database K023683
Across registries
- FDA 510(k) K023683 decided 1 Dec 2003 Active
- FDA GUDID UDI-DI 10884389121269 listed 5 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K023683
- Listed FDA GUDID 10884389121269
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medline
- Generic name
- Resuscitator face mask, single-use
- Model / Ref / Catalog
- HCS64184
- Primary DI / UDI-DI
- 10884389121269
- 510(k) Number
- FDA product code
- CBP
- GMDN term
- Resuscitator face mask, single-use
- Device class
- Class II
- Regulation number
- 868.5870
- GUDID distribution status
- In Commercial Distribution
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