FDA UDI
In Commercial Distribution
🇺🇸 United States
Medviron Huron Bassinet
DI: 10851477007033
·
Model: Single Drawer
·
MEDVIRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medviron Huron Bassinet
- Primary DI
- 10851477007033
- Version / Model
- Single Drawer
- Catalog Number
- M13-0000-0000
- Company Name
- MEDVIRON LLC
- Labeler DUNS
- 079795848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 30078c2a-eaab-4c72-91a9-9b2168b9f0d0
Device Description
Medviron Huron Bassinet, I drawer with standard pull.
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 |
|---|---|---|---|---|
| 60920 | Infant-hammock bed mattress | A foam-filled case with a central meshed/netted depression/hole designed to be placed in a cot/crib/bassinet/bed/incubator and to cradle a young infant during sleep/rest, and can used for phototherapy, transportation and burns patients. It is available in various shapes and sizes and is not intended to be placed on an existing mattress. The breathable netting is intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and hyperthermia. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851477007033 | GS1 |
Customer Contacts
- Phone
- 616-741-9663
- [email protected]