FDA UDI
In Commercial Distribution
🇺🇸 United States
SpiroScout SP Plus
DI: 07613365500035
·
Model: D
·
Ganshorn Medizin Electronic GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SpiroScout SP Plus
- Primary DI
- 07613365500035
- Version / Model
- D
- Catalog Number
- 013400563
- Company Name
- Ganshorn Medizin Electronic GmbH
- Labeler DUNS
- 318498177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- dbda722b-2a8b-4917-ba32-10aad1e145ae
Device Description
The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2 The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 | 07613365500035 | GS1 |
Customer Contacts
- Phone
- +49977162220
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 60 – 106 KiloPascal