FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCUSYNC
DI: 00860008802033
·
Model: 7200-3P
·
Accusync Medical Research Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ACCUSYNC
- Primary DI
- 00860008802033
- Version / Model
- 7200-3P
- Catalog Number
- 7200-3P
- Company Name
- Accusync Medical Research Corporation
- Labeler DUNS
- 060000759
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-08
- Public Version
- 1
- Public Version Date
- 2024-11-18
- Public Version Status
- New
- Public Device Record Key
- 0db475c2-f9c2-4bdc-9ac2-23104a15f3b6
Device Description
ACCUSYNC 72 3 LEAD CARDIAC TRIGGER MONITOR WITH PRINTER OPTION
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
- 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 |
|---|---|---|---|---|
| IYY | Synchronizer, Electrocardiograph, Nuclear | Radiology | 892.1410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36561 | Patient monitoring system module, cardiac output | A small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008802033 | GS1 |
Customer Contacts
- Phone
- 203-877-1610
- [email protected]