FDA UDI
In Commercial Distribution
🇺🇸 United States
Medviron
DI: 00851477007227
·
Model: Guardian Rise Bassinet
·
MEDVIRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medviron
- Primary DI
- 00851477007227
- Version / Model
- Guardian Rise Bassinet
- Catalog Number
- M06-0000-0000
- Company Name
- MEDVIRON LLC
- Labeler DUNS
- 079795848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-05
- Public Version
- 2
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- f4baffda-e117-4fe7-8e2d-0b3f8a5f2018
Device Description
Height Adjustable Bassinet
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 | 00851477007227 | GS1 |
Customer Contacts
- Phone
- 6167419663
- [email protected]