Babi.Plus Bubble PAP Valve 0-10cmH2O
GUDID 44710810100794
Distributed by Teleflex
GALEMED CORPORATION
PEEP valve, reusable| Primary Device ID | 44710810100794 |
| NIH Device Record Key | 3eab8646-870d-47bc-807a-60b642c4f5e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Babi.Plus |
| Version Model Number | BC01-HD |
| Catalog Number | Bubble PAP Valve 0-10cmH2O |
| Company DUNS | 656854379 |
| Company Name | GALEMED CORPORATION |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04710810100796 [Primary] |
| GS1 | 24710810100790 [Package] Contains: 04710810100796 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 44710810100794 [Package] Contains: 24710810100790 Package: Carton [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090317
FDA Product Code
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [Babi.Plus]
| 44710810093577 | BC01-AU |
| 44710810119741 | B024 |
| 44710810119734 | B023 |
| 44710810119727 | B022 |
| 44710810119710 | B021 |
| 44710810119703 | B020 |
| 44710810100800 | Distributed by Teleflex |
| 44710810100794 | Distributed by Teleflex |
| 04710810093579 | BC01-AU |
| 44710810093560 | BC23-AU |
| 44710810117525 | PA01 |
| 44710810093553 | BC51-AU |
| 04710810105265 | BC01-AU |
Trademark Results [Babi.Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BABI.PLUS 77642836 3764949 Live/Registered |
GALEMED CORPORATION 2009-01-03 |
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