FDA UDI
In Commercial Distribution
🇺🇸 United States
VitaloJAK
DI: 15099169715100
·
Model: 7100
·
VITALOGRAPH (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- VitaloJAK
- Primary DI
- 15099169715100
- Version / Model
- 7100
- Company Name
- VITALOGRAPH (IRELAND) LIMITED
- Labeler DUNS
- 219683489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-17
- Public Version
- 3
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 654bd161-d12f-4d55-a65e-eeb14a097b4b
Device Description
Base VITALOJAK INTERNATIONAL WEST(1)
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 |
|---|---|---|---|---|
| DSH | RECORDER, MAGNETIC TAPE, MEDICAL | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62276 | Cough ambulatory recording system | An assembly of devices intended for 24-hour detection and recording of the number of times a patient coughs during daily activities or sleep, typically in the assessment of patients affected by various disorders associated with coughing (e.g., asthma, COPD). It typically consists of body-worn microphones and acoustic sensors designed to detect coughing sounds, and a small battery-powered portable recorder for registering the data. The recorded data is typically downloaded for analysis at a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05099169715103 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 15099169715100 | GS1 | ||||
| Package | 05099169710214 | GS1 | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110525 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity