| Primary Device ID | 00383730004648 |
| NIH Device Record Key | b9376750-60bd-4203-8759-378f9c8e8951 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OVAL MOUTHPIECE |
| Version Model Number | 1136960 |
| Catalog Number | 1136960 |
| 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 | true |
| 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 | 00383730004648 [Primary] |
| BZH | METER, PEAK FLOW, SPIROMETRY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-19 |
| Device Publish Date | 2020-06-11 |
| 00383730004648 - OVAL MOUTHPIECE | 2020-06-19OVAL MOUTHPIECE |
| 00383730004648 - OVAL MOUTHPIECE | 2020-06-19 OVAL MOUTHPIECE |
| 00383730004624 - PLASTIC PEDIATRIC MOUTHPIECES (715)100PK | 2020-06-17 PLASTIC PEDIATRIC MOUTHPIECES (715)100PK |
| 00383730004631 - PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE | 2020-06-17 PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE |
| 00383730004617 - OVAL DISPOSABLE PLASTIC MOUTHPIECE | 2020-06-15 OVAL DISPOSABLE PLASTIC MOUTHPIECE |
| 00383730004495 - TBM MP Gold Chamber Assy Tested | 2020-04-01 Tidal Breathing Mode Mouthpiece Gold Chamber Assembly Tested |
| 00383730004501 - I-neb Clinical Study Disc | 2020-04-01 I-neb Clinical Study Disc |
| 00383730004518 - I-neb Generic ClinicalStudy Disc Power10 | 2020-04-01 I-neb Generic Clinical Study Disc Power10 |
| 00383730004587 - I-neb In Vitro Test Disc Power 10 | 2020-04-01 I-neb In Vitro Test Disc Power 10 |