FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Medical Devices
DI: 00813880023133
·
Model: 4220
·
TRINITY MEDICAL DEVICES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Trinity Medical Devices
- Primary DI
- 00813880023133
- Version / Model
- 4220
- Company Name
- TRINITY MEDICAL DEVICES INC.
- Labeler DUNS
- 078728314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-02-11
- Public Version
- 1
- Public Version Date
- 2023-02-20
- Public Version Status
- New
- Public Device Record Key
- c40e0032-5d58-4ec4-8e21-6180700a049e
Device Description
NeoGuardMiniReflectors,1inx7/8in
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15752 | Infant heat shield | A protective guard intended to be used to reduce heat loss due to insensible water loss, i.e., evaporation, during the radiant warming of primarily premature infants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00813880023256 | GS1 | ||||
| Primary | 00813880023133 | GS1 |