Spiro PD
Basic Information
- Brand Name
- Spiro PD
- Primary DI
- 00857845006007
- Version / Model
- 1.0
- Catalog Number
- 10000101
- Company Name
- PMD HEALTHCARE, INC.
- Labeler DUNS
- 003229849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- ea898773-5131-48b8-88d4-e303ddba615a
Device Description
The Spiro PD personal spirometer is a hand held device that is used to test the user’s lung capacity. Measures of air flow and volume are indicators of lung health. By blowing into the tube of the Spiro PD the user can see a measure of his/her forced expiratory volume for one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF), and forced expiratory flow from 25% to 75% (FEF 25/75). The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is intended to be used as a single-patient device only and can be used in any setting - home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: • 2-12 years - Child • 13-21 years - Adolescent • 22 and over- Adult.
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
- 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 | 00857845006007 | GS1 |
Customer Contacts
- Phone
- 8887634968
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103575 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius