FDA UDI
In Commercial Distribution
🇺🇸 United States
CardioCard Holter
DI: G466CUSBHOLT0
·
Model: CUSBHOLTER
·
NASIFF ASSOCIATES INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CardioCard Holter
- Primary DI
- G466CUSBHOLT0
- Version / Model
- CUSBHOLTER
- Catalog Number
- CC-HOLTER
- Company Name
- NASIFF ASSOCIATES INC
- Labeler DUNS
- 612902684
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-04
- Public Version
- 1
- Public Version Date
- 2023-04-12
- Public Version Status
- New
- Public Device Record Key
- ce2c78ce-2d90-4d27-9124-bfcc26b9f6bb
- Distribution End Date
- 2100-03-17
Device Description
Cardio Card Holter, Ambulatory, Mobile System.
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
- 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 |
|---|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36827 | Electrocardiographic long-term ambulatory recording analyser | An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G466CUSBHOLT0 | HIBCC |
Customer Contacts
- Phone
- 3156762346
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960544 | 000 |