FDA UDI
In Commercial Distribution
🇺🇸 United States
Midmark IQspiro® Digital Spirometer with Calibration Syringe
DI: 00841709100338
·
Model: 4-000-0026
·
MIDMARK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midmark IQspiro® Digital Spirometer with Calibration Syringe
- Primary DI
- 00841709100338
- Version / Model
- 4-000-0026
- Catalog Number
- 4-000-0026
- Company Name
- MIDMARK CORPORATION
- Labeler DUNS
- 005036025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- bd105fac-2234-45dd-b8b0-735ed00a9212
Device Description
The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro® operates with a Windows-compatible computer using a USB port connection and the Midmark software. This Kit contains the IQcal® 3-Litre Calibration Syringe.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BZG | Spirometer, Diagnostic | Anesthesiology | 868.1840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13680 | Diagnostic spirometer, professional | An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841709100338 | GS1 |
Customer Contacts
- Phone
- 1-800-624-8950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7.75" x 2.5" x 1.75"; Weight: 9 oz. |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.