FDA UDI
In Commercial Distribution
🇺🇸 United States
Benson
DI: 04260176128304
·
Model: CCS-200 Spirometer
·
MAICO Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Benson
- Primary DI
- 04260176128304
- Version / Model
- CCS-200 Spirometer
- Company Name
- MAICO Diagnostics GmbH
- Labeler DUNS
- 344863550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-15
- Public Version
- 2
- Public Version Date
- 2024-01-22
- Public Version Status
- Update
- Public Device Record Key
- 6f87eac1-c56c-4bd6-a339-f9f231388ba4
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
- 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 |
|---|---|---|---|---|
| 35353 | Monitoring spirometer, electrical | A mains electricity (AC-powered) device designed to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. It may also be used to measure the tidal volume, minute volume, and respiration rate delivered to a patient via the expiratory ports of resuscitation devices, such as transport ventilators and resuscitators, to evaluate their performance. The device may incorporate high and low tidal volume alarms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260176128304 | GS1 |