FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DeVilbiss
DI: 00885304001164
·
Model: DV51D-HH-S
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DeVilbiss
- Primary DI
- 00885304001164
- Version / Model
- DV51D-HH-S
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 2
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 3b941064-6129-48a4-b7b0-e86b25496c36
- Distribution End Date
- 2024-01-29
Device Description
Product Description IntelliPAP Std w/HH&SmrtLnk Mod.&Dta Crd
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
- 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 |
|---|---|---|---|---|
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14359 | Ventilator IMV controller | An unit that, added to a ventilator otherwise incapable of providing intermittent mandatory ventilation (IMV) or synchronized intermittent mandatory ventilation (SIMV) functions, permits the ventilator to provide this kind of breathing mode to the patient during his/her attempts at spontaneous breathing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885304001164 | GS1 |