| Primary Device ID | 20815090010068 |
| NIH Device Record Key | e413a6e5-82fa-4571-8348-5c981e28072e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bebe Keeper Kover |
| Version Model Number | 16-3 |
| Catalog Number | 16-3 |
| Company DUNS | 002657679 |
| Company Name | SMALL BEGINNINGS INC |
| Device Count | 6 |
| 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 | 00815090010064 [Primary] |
| GS1 | 00815090012075 [Unit of Use] |
| GS1 | 10815090010061 [Package] Contains: 00815090010064 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 20815090010068 [Package] Contains: 10815090010061 Package: Case [6 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 |
| 10815090010023 - Pacee Pacifier | 2020-10-02 Lil' Pacee preemie pacifier intended to soothe infants in the NICU especially for use with respiratory products. |
| 10815090010009 - Bili-Bonnet | 2020-08-11 Bili-Bonnet Preemie size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice. |
| 10815090010016 - Bili-Bonnet | 2020-08-11 Bili-Bonnet Newborn size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice. |
| 10815090010177 - Bili-Bonnet | 2020-08-11 Bili-Bonnet Ultra-Preemie size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice. |
| 00815090012785 - Tender and Tiny Tourniquets | 2020-08-11 TnT Tourniquets preemie size for infants in the NICU to be used to bring forth the veins during IV or blood sampling. |
| 10815090012461 - Tender and Tiny Tourniquets | 2020-08-11 TnT Tourniquets preemie size for infants heads in the NICU to be used to bring forth the veins during IV or blood sampling. |
| 10815090011433 - Webeonkers | 2020-07-01 Webeonkers Ultra-Preemie Oral/Nasal Suction Device is intended to be attached to wall suction and used as an oral or nasal cavit |
| 20815090010044 - Bebeonkers II | 2019-02-21 The Bebeonkers II Oral/Nasal Suction Device is intended to be attached to wall suction and used as an oral or nasal cavity evacu |