FDA UDI
In Commercial Distribution
🇺🇸 United States
Model 4000
DI: 15099169400341
·
Model: 4000
·
VITALOGRAPH (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Model 4000
- Primary DI
- 15099169400341
- Version / Model
- 4000
- Company Name
- VITALOGRAPH (IRELAND) LIMITED
- Labeler DUNS
- 219683489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-08
- Public Version
- 4
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- 89bddf9f-891b-4a5c-9ebb-3c4ef8e5ae6e
Device Description
3999 RESPIRATORY MONITOR ASMA-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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZG | SPIROMETER, DIAGNOSTIC | Anesthesiology | 868.1840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46906 | Expiratory peak flow meter, digital | A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35099169400345 | GS1 | 25 | In Commercial Distribution | ||
| Package | 05099169400344 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 15099169400341 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073155 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity