| Primary Device ID | 00850644007657 | 
| NIH Device Record Key | 8c2640c5-47ac-4d53-af89-445abefe61ae | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Medium-Large Adult mouthpiece 100/bx | 
| Version Model Number | 1001-BULK | 
| Catalog Number | 1001-BULK | 
| Company DUNS | 077967081 | 
| Company Name | Vacumed | 
| Device Count | 100 | 
| 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 | 00850644007657 [Primary] | 
| GS1 | 08506440076572 [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 |