FDA UDI
In Commercial Distribution
🇺🇸 United States
EverGo Kit
DI: 00848530051068
·
Model: OF1005SP
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EverGo Kit
- Primary DI
- 00848530051068
- Version / Model
- OF1005SP
- Catalog Number
- OF1005SP
- 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
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- 0b804efd-310b-4f02-b91b-b35ec1664ec5
Device Description
This kit contains: 2 OF1005 Foam Cabinet Filters, 1 BF316 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 | Local/regional anaesthesia conduction filter | A microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during subcutaneous administration to a patient (e.g., through a spinal or epidural catheter); it may in addition be intended for use during medication administration or preparation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530051068 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]