| Primary Device ID | 00383730001180 |
| NIH Device Record Key | 361387ff-7584-48b3-8728-3c0aa49ff11d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MASK - OC Advanced |
| Version Model Number | 00 |
| Catalog Number | HS81311 |
| Company DUNS | 220018415 |
| Company Name | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383730001180 [Primary] |
| CAF | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-24 |
| 00383730001203 | OC Advanced Adult Large Mask, 10-pack |
| 00383730001197 | Oc Advanced Lark Mask (81310EU), Single Unit |
| 00383730001180 | OC Advanced Adult Large Mask |
| 00383730001166 | OC Advanced Medium Pediatric Mask, Single Unit |
| 00383730001159 | OC Advanced Pediatric Medium Mask |
| 00383730001142 | OC Advanced Pediatric Small Mask |
| 00383730001135 | OC Advanced Small Pediatric Mask, Single Unit |
| 00383730001128 | OC Advanced Pediatric Small Mask |