FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCUCART
DI: 06972077026037
·
Model: MCE395-BL
·
XIAMEN TAFT MEDICAL CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCUCART
- Primary DI
- 06972077026037
- Version / Model
- MCE395-BL
- Company Name
- XIAMEN TAFT MEDICAL CO.,LTD.
- Labeler DUNS
- 530563253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-26
- Public Version
- 1
- Public Version Date
- 2026-04-03
- Public Version Status
- New
- Public Device Record Key
- 653b9cc4-921c-4b12-b7b2-35ab560f423d
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
- 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 |
|---|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Anesthesiology | 868.6175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46978 | Cardiopulmonary resuscitation cabinet, unequipped | An enclosed mobile cart designed to store/transport devices and supplies used in emergency resuscitation procedures. It typically consists of a shelf/drawer cupboard structure on wheels used to store and provide ready access to instruments and materials. It includes appropriate hardware to attach accessories [e.g., hangers for intravenous (IV) solution containers, supports for an oxygen (O2) cylinder and/or a backboard] and has a working surface for performing treatment. This cabinet may have either hinged or sliding doors, built-in grounded electrical outlets, and security locks. It must be fitted with the resuscitation devices, equipment and supplies before it can be used as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972077026037 | GS1 |