FDA UDI
In Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 50822383116483
·
Model: HUM 001
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 50822383116483
- Version / Model
- HUM 001
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 1
- Public Version Date
- 2019-07-01
- Public Version Status
- New
- Public Device Record Key
- f7e71d46-10ca-4c16-ac6d-6aef66c30ce7
Device Description
RespiratoryRespiratory Disposables Product Description: Humidifier Bottle Pl 50/CS
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
- 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 |
|---|---|---|---|---|
| KFZ | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE) | Anesthesiology | 868.5460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36857 | Ultrasonic respiratory humidifier | A mains electricity (AC-powered) device designed to agitate water into micro-particles to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00822383116488 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 50822383116483 | GS1 |