FDA UDI
In Commercial Distribution
🇺🇸 United States
SPIROTRAC
DI: 65099169688003
·
Model: 7000
·
VITALOGRAPH (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SPIROTRAC
- Primary DI
- 65099169688003
- Version / Model
- 7000
- Company Name
- VITALOGRAPH (IRELAND) LIMITED
- Labeler DUNS
- 219683489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 3
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 57d7f0d5-d820-4e4e-a541-d46c0fdebcdd
Device Description
7000 SPIROTRAC
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
- Yes
- 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 |
|---|---|---|---|---|
| BZG | SPIROMETER, DIAGNOSTIC | Anesthesiology | 868.1840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64339 | Cardiopulmonary parameter spot-check measurement software | An application software program intended to be installed on a computer/workstation to assist a healthcare provider in the spot-check (user-initiated) measurement of a cardiovascular and/or pulmonary parameter(s) [e.g., blood pressure, electrocardiography (ECG), respiratory rate, haemoglobin oxygen saturation (SpO2)]; it might also be intended for additional physiological measurements [e.g., electromyography (EMG), galvanic skin response (GSR)]. It is intended to display, store, and allow communication of the physiological data, and may include interpretive algorithms to assist diagnosis; it is not intended for continuous bedside/intraoperative monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05099169688001 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 65099169688003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141546 | 000 |