FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardio Server
DI: 00732094360295
·
Model: 901204
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cardio Server
- Primary DI
- 00732094360295
- Version / Model
- 901204
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-18
- Public Version
- 2
- Public Version Date
- 2026-02-27
- Public Version Status
- Update
- Public Device Record Key
- 7355dca6-47d7-45c9-8abb-c201e6e47266
Device Description
Web-Enabled, Server-Based, Multi-Modality Database supporting the enterprise with up to 250 concurrent users. Includes- Secure access, digital signature, critical alert logs, HIPAA logs, report archiving, backup support, Active Directory/LDAP compatible, and enhanced reporting including 20+ preconfigured reports. Includes 1 Hospital. Excludes hardware. v7.x
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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| DQK | Computer, diagnostic, programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44098 | Cardiology information system application software | An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094360295 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052883 | 000 |