FDA UDI
In Commercial Distribution
🇺🇸 United States
THS Neonatal Cart
DI: 00628678604056
·
Model: MED-FB4EP2I4T
·
CGC Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- THS Neonatal Cart
- Primary DI
- 00628678604056
- Version / Model
- MED-FB4EP2I4T
- Company Name
- CGC Technologies Inc
- Labeler DUNS
- 204154467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-24
- Public Version
- 1
- Public Version Date
- 2023-11-01
- Public Version Status
- New
- Public Device Record Key
- f12302ad-6f1d-4ec8-80fc-839b33881644
Device Description
Medical device cart to hold the necessary devices to accompany the patient in intra-hospital movements.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Anesthesiology | 868.6175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40596 | Electromechanical device/system transport trolley | A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628678604056 | GS1 | ||||
| Package | 10628678604053 | GS1 | Boxed Pallet | 1 | In Commercial Distribution |