FDA UDI
In Commercial Distribution
🇺🇸 United States
Powerheart® MDLink
DI: 00812394021321
·
Model: 400621-046
·
Zoll Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Powerheart® MDLink
- Primary DI
- 00812394021321
- Version / Model
- 400621-046
- Catalog Number
- 400621-046
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-02
- Public Version
- 4
- Public Version Date
- 2022-02-08
- Public Version Status
- Update
- Public Device Record Key
- 56bbc5dc-7414-47db-ac06-50113c92c0ae
Device Description
MDLink SW 10.16
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
- 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 |
|---|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41581 | External defibrillator application software | An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a defibrillator intended for external use on the thorax so that it may function according to its intended purpose. A basic set of applications programs and routines are included with the defibrillator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812394021321 | GS1 | ||||
| Previous | 00812394020393 | GS1 |
Customer Contacts
- Phone
- +1.262.953.3500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102496 | 000 |