| Primary Device ID | 00383730000343 |
| NIH Device Record Key | e20a5ca8-1db9-4eba-97b9-fafe3aeddd86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTICHAMBER DIAMOND |
| Version Model Number | 00 |
| Catalog Number | 1098215 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383730000343 [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 | 2018-11-12 |
| Device Publish Date | 2016-08-24 |
| 00383730003924 | OPTICHAMBER DIAMOND WLG MASK CHINA (P10) |
| 00383730003917 | OPTICHAMBER DIAMOND WMED MASK CHINA (P10) |
| 00383730003900 | OPTICHAMBER DIAMOND WSMALL MASK CHINA (P10) |
| 00383730003894 | OPTICHAMBER DIAMOND CHINA (P10) |
| 00383730000633 | ASTHMAPACK FOR CHILDREN, 10-Pack |
| 00383730000626 | ASTHMA PACK FOR ADULTS, 10 Pack |
| 00383730000527 | DIAMOND WITH MED MASK-PREFERRED PLUS |
| 00383730000510 | DIAMOND WITH LG MASK-PREFERRED PLUS |
| 00383730000503 | DIAMOND WITH SM MASK-PREFERRED PLUS |
| 00383730000497 | DIAMOND-PREFERRED PLUS |
| 00383730000381 | OPTICHAMBER DIAMOND WMED MASK (RUSSIA) |
| 00383730000374 | OPTICHAMBER DIAMOND WSML MASK (RUSSIA) |
| 00383730000350 | OPTICHAMBER DIAMOND W LG MASK CANADA |
| 00383730000343 | OPTICHAMBER DIAMOND W MED MASK CANADA |
| 00383730000336 | OPTICHAMBER DIAMOND W SM MASK- CANADA |
| 00383730000329 | OPTICHAMBER DIAMOND - 10-PACK CANADA |
| 00383730000268 | OC DIAMOND 50 PACK |
| 00383730000251 | OPTICHAMBER DIAMOND W LRG MSK- ROW |
| 00383730000244 | OC DIAMOND W LARGE MASK 10 PK- US |
| 00383730000220 | OC DIAMOND W MEDIUM MASK 10 PK- US |
| 00383730000213 | OPTICHAMBER DIAMOND W MED MSK- ROW |
| 00383730000206 | OC DIAMOND W SMALL MASK 10 PK- US |
| 00383730000190 | OPTICHAMBER DIAMOND W SMALL MASK- ROW |
| 00383730000183 | OPTICHAMBER DIAMOND - ROW |
| 00383730000176 | OPTICHAMBER DIAMOND - 10 PACK |
| 00383730000145 | OptiChamber Diamond Anti-Static Valved Holding Chamber |