| Primary Device ID | 10709078008112 |
| NIH Device Record Key | 48605574-56cf-474a-b129-d99794a548a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anesthesia Mask |
| Version Model Number | 7-9903 |
| 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 | true |
| Serial Number | false |
| 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 | 00709078008115 [Primary] |
| GS1 | 10709078008112 [Package] Contains: 00709078008115 Package: [20 Units] In Commercial Distribution |
| BSJ | Mask, Gas, Anesthetic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2019-10-18 |
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| 10709078008150 | Anesthesia Mask Comfort Soft Plus , Medium Adult w/Hook ring |
| 10709078008143 | Comfort Soft Plus Anesthesia Mask Large Adult w/Hook Ring |
| 10709078008136 | Anesthesia Mask Neonate W/Hook Series 900 |
| 10709078008129 | Anesthesia Mask Infant 900 Series |
| 10709078008112 | Anesthesia Mask Pediatric w/Hook Ring, Series 900 |
| 10709078008105 | Anesthesia Mask, Small Adult w/Hook ring series 900 |
| 10709078008099 | Anesthesia Mask Series 900 Medium Adult w/Hook ring |
| 10709078008082 | Anesthesia Mask Series 900 Large Adult w/Hook Ring |
| 10709078012331 | Anesthesia Mask, Medium Mask, Series 800, Bulk |
| 10709078012317 | Anesthesia Mask, Large Adult, Series 800, Bulk |
| 10709078011471 | Anesthesia Mask, Large Adult, Series 900 with Hole, Bulk |
| 10709078013901 | Adult Medium Anesthesia Mask, Blue Hook Ring |