| Primary Device ID | 00850644007602 |
| NIH Device Record Key | 15528116-6512-4886-8c60-a4519c5ef64b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric mouthpiece 10/bx |
| Version Model Number | 1004 |
| Catalog Number | 1004 |
| Company DUNS | 077967081 |
| Company Name | Vacumed |
| Device Count | 10 |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com | |
| Phone | +1(800)235-3333 |
| info@vacumed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850644007602 [Primary] |
| GS1 | 08506440076022 [Unit of Use] |
| BYP | MOUTHPIECE, BREATHING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2018-10-05 |
| 00850644007169 - Disposable Mouthpiece 19mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007176 - Disposable Mouthpiece 19mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007206 - Disposable Mouthpiece 22mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007213 - Disposable Mouthpiece 22mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007220 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007237 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007244 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007251 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |