| Primary Device ID | 10815090010009 |
| NIH Device Record Key | 47344a30-c266-4208-8586-48d0c82b6a0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bili-Bonnet |
| Version Model Number | 01A |
| Catalog Number | 01A |
| Company DUNS | 002657679 |
| Company Name | SMALL BEGINNINGS INC |
| Device Count | 1 |
| 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 | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| Phone | 760-949-7707 |
| kelly@small-beginnings.com | |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815090010002 [Primary] |
| GS1 | 10815090010009 [Package] Contains: 00815090010002 Package: BOX [50 Units] In Commercial Distribution |
| GS1 | 20815090010006 [Package] Package: CASE [4 Units] In Commercial Distribution |
| FOK | Pad, Neonatal Eye |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-11 |
| Device Publish Date | 2020-08-03 |
| 10815090010177 | Bili-Bonnet Ultra-Preemie size phototherapy masks to protect infants eyes from phototherapy for |
| 10815090010016 | Bili-Bonnet Newborn size phototherapy masks to protect infants eyes from phototherapy for treatm |
| 10815090010009 | Bili-Bonnet Preemie size phototherapy masks to protect infants eyes from phototherapy for treatm |