| Primary Device ID | 10709078014236 |
| NIH Device Record Key | 852f5779-1042-473c-a1e5-f936e8c38e46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HME Filter |
| Version Model Number | 1002258 |
| Company DUNS | 092673953 |
| Company Name | WESTMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078014239 [Primary] |
| GS1 | 10709078014236 [Package] Contains: 00709078014239 Package: [50 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-08 |
| Device Publish Date | 2022-03-31 |
| 00709078049996 - Filter | 2025-10-01 Entered in error |
| 00709078050008 - Filter | 2025-10-01 Entered in error |
| 10709078008402 - Flex Extenders | 2024-10-03 Flex Extender, 5.2" x 15mm OD x 22/15mm ID |
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| 20889483612009 - Anesthesia Circuit Kit | 2024-06-10 60" Adult Anesthesia Circuit; Swivel Wye, 2L LF Bag |
| 20889483612016 - Anesthesia Circuit Kit | 2024-06-10 60" Adult Anes. Circuit; Par-Wye, GSE, 2L Latex Free |
| 20889483612023 - Anesthesia Circuit Kit | 2024-06-10 60" Pediatric Anes. Circuit, Par-Wye, GSE W/Port |
| 20889483612030 - Anesthesia Circuit Kit | 2024-06-10 UniLim,120" Adult.Coa.Circuit,Elbow,24Flex Expiratory |