FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 24710810111291
·
Model: 4521
·
GALEMED CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 24710810111291
- Version / Model
- 4521
- Catalog Number
- Exhalometer
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 3
- Public Version Date
- 2024-10-24
- Public Version Status
- Update
- Public Device Record Key
- 62a7b998-0718-49f0-bd45-e025c35af7bb
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Anesthesiology | 868.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61544 | Monitoring spirometer, mechanical | A portable mechanical device designed to continuously measure tidal and/or minute volume of a spontaneously-breathing or mechanically-ventilated patient, for the evaluation of the patient’s ventilatory status during intensive care treatment, anaesthesia, and postoperative recovery; it may also be used to measure tidal/minute volume and respiration rate delivered to a patient via the expiratory ports of resuscitation devices to evaluate their performance. It consists of an airflow-driven turbine/dial which indicates the air volume passed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810111295 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 24710810111291 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius