FDA UDI
In Commercial Distribution
🇺🇸 United States
Invacare Perfect O2 Kit
DI: 00848530081324
·
Model: OF9004SP-1
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Invacare Perfect O2 Kit
- Primary DI
- 00848530081324
- Version / Model
- OF9004SP-1
- Catalog Number
- OF9004SP-1
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-31
- Public Version
- 1
- Public Version Date
- 2018-08-31
- Public Version Status
- New
- Public Device Record Key
- e6acf414-1997-42c0-a5a3-26a1255b7cc4
Device Description
This kit contains: 1 OF9004 Foam Cabinet Filters, 1 BFH6S HEPA FIlter, 1 BF516 Final Bacteria Filter.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31245 | Anaesthesia conduction filter | A sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530081324 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]