FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoLight Bassinet Basket Loaner
DI: 00852788008101
·
Model: 300064
·
NEOLIGHT LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeoLight Bassinet Basket Loaner
- Primary DI
- 00852788008101
- Version / Model
- 300064
- Catalog Number
- NEO-BASK-LNR
- Company Name
- NEOLIGHT LLC
- Labeler DUNS
- 074301687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-09
- Public Version
- 1
- Public Version Date
- 2025-04-17
- Public Version Status
- New
- Public Device Record Key
- a27c8a69-2811-4bb7-92ab-8ed0001edf38
Device Description
The NeoLight Bassinet Basket Loaner is a component of a non-powered medical bassinet, intended to work effortlessly with Stryker’s Nära Bassinet’s wheeled base and mattress, offering an adjustable sleeping surface for infants. Constructed from clear, durable, BPA-free high-impact resistant plastic, the basket features an open top and four fixed walls to securely hold the pediatric patient.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| NZG | Bassinet, Hospital | General Hospital | 880.5145 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38140 | Neonatal bed | A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852788008101 | GS1 |
Customer Contacts
- Phone
- 1-866-934-8945
- [email protected]