Identity
- Trade Name
- Mac-Lab FDA UDI
- Generic Name
- Cardiac catheterization monitoring system FDA UDI
- Device Name
- SOFTWARE MAC-LAB V6.9.6 R3 FDA UDI
- Model / Reference
- v6.9.6 R3 FDA UDI
- Description
- SOFTWARE MAC-LAB V6.9.6 R3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682123556 FDA UDI
- 510(k) Number
- K130626 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac catheterization monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac catheterization monitoring systemCardiac electrophysiology analysis system
Mac-Lab by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ge Medical Systems Information Technologies, Inc.
Sources (1)
- FDA UDI e672ae60-6306-441c-91e8-8a51584c5103 34 fields · synced Jun 8, 2026