FDA UDI
In Commercial Distribution
🇺🇸 United States
AtriCure System Cart
DI: 10840143901522
·
Model: ASCB2
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AtriCure System Cart
- Primary DI
- 10840143901522
- Version / Model
- ASCB2
- Catalog Number
- A000842
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-11
- Public Version
- 1
- Public Version Date
- 2021-01-19
- Public Version Status
- New
- Public Device Record Key
- 8bdb88da-072a-4292-a27f-70e3e80becd8
Device Description
Basic Cart
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 |
|---|---|---|---|---|
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Ophthalmic | 886.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34909 | Instrument trolley | A cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840143903438 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 10840143901522 | GS1 | ||||
| Previous | 00818354011906 | GS1 |
Customer Contacts
- Phone
- 866-349-2342
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -35 – 54 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity