FDA UDI
In Commercial Distribution
🇺🇸 United States
BiliCocoon™ Bag Disposable
DI: 03760012570089
·
Model: BCC221
·
NEOMEDLIGHT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BiliCocoon™ Bag Disposable
- Primary DI
- 03760012570089
- Version / Model
- BCC221
- Catalog Number
- BCC221
- Company Name
- NEOMEDLIGHT
- Labeler DUNS
- 265910339
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-03
- Public Version
- 4
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- e388f353-554f-45e0-9577-87a82b7383dc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | General Hospital | 880.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47456 | Basic bed sheet, single-use | A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03760012570072 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 03760012570089 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163526 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius