FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DeVilbiss iFill
DI: 00885304000860
·
Model: 535I
·
DEVILBISS HEALTHCARE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DeVilbiss iFill
- Primary DI
- 00885304000860
- Version / Model
- 535I
- Catalog Number
- 535I
- Company Name
- DEVILBISS HEALTHCARE LLC
- Labeler DUNS
- 962175894
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-06
- Public Version
- 5
- Public Version Date
- 2024-11-04
- Public Version Status
- Update
- Public Device Record Key
- 3d6197d6-585a-45b6-b40b-b8002ced9f33
- Distribution End Date
- 2024-11-01
Device Description
Portable Oxygen Station
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
- 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 |
|---|---|---|---|---|
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61605 | Oxygen compressor, home-use | A mains electricity (AC-powered) electromechanical device intended to be used in conjunction with a stationary oxygen concentrator to pressurize and fill/refill ambulatory oxygen cylinders with medical oxygen (O2). It is operated by the patient in the home to facilitate mobile oxygen therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885304000860 | GS1 |
Customer Contacts
- Phone
- 800-338-1988
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053240 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius