| Primary Device ID | 00815090011382 |
| NIH Device Record Key | e9aea60b-e9d8-4458-82a8-f2dfae47d7b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bebeonkers II |
| Version Model Number | 16-2KK |
| Catalog Number | 16-2KK |
| Company DUNS | 002657679 |
| Company Name | SMALL BEGINNINGS INC |
| Device Count | 3 |
| 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 | 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 |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815090011382 [Primary] |
| GS1 | 00815090012099 [Unit of Use] |
| GS1 | 10815090011389 [Package] Package: Box [50 Units] In Commercial Distribution |
| GS1 | 20815090011386 [Package] Contains: 10815090011389 Package: Case [4 Units] In Commercial Distribution |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-09-24 |
| 00815090011382 | The Bebeonkers II Oral/Nasal Suction Device for the Ultra Preemie infant with Bebe Keeper Kover |
| 20815090010044 | The Bebeonkers II Oral/Nasal Suction Device is intended to be attached to wall suction and used |