FDA UDI
In Commercial Distribution
🇺🇸 United States
Fresenius
DI: 04046241091700
·
Model: M52836
·
Fresenius Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fresenius
- Primary DI
- 04046241091700
- Version / Model
- M52836
- Company Name
- Fresenius Usa, Inc.
- Labeler DUNS
- 076594100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-02
- Public Version
- 3
- Public Version Date
- 2018-10-22
- Public Version Status
- Update
- Public Device Record Key
- 46c2e63a-2596-4157-a404-82376539488e
Device Description
JUG WAND, BLUE
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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KDI | Dialyzer, high permeability with or without sealed dialysate system | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32110 | Haemodialysis dialysate tubing, single-use | A sterile length of flexible tube, typically made of synthetic polymer material(s), intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046241091700 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2572
- [email protected]