FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Asthma Monitor AM1+
DI: 04057155000177
·
Model: AM1+
·
eResearchTechnology GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Asthma Monitor AM1+
- Primary DI
- 04057155000177
- Version / Model
- AM1+
- Company Name
- eResearchTechnology GmbH
- Labeler DUNS
- 341625331
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-15
- Public Version
- 6
- Public Version Date
- 2024-04-01
- Public Version Status
- Update
- Public Device Record Key
- 697bbd60-4094-43b8-b963-7d66279b1164
- Distribution End Date
- 2024-03-31
Device Description
Asthma Monitor, electronic peak flow meter
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04057155000177 | GS1 |
Customer Contacts
- Phone
- +4993057209891
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090486 | 000 |