FDA UDI
In Commercial Distribution
🇺🇸 United States
Locking Titanium Adapter for Peritoneal Dialysis Catheter
DI: 00085412007403
·
Model: 5C4129
·
BAXTER INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Locking Titanium Adapter for Peritoneal Dialysis Catheter
- Primary DI
- 00085412007403
- Version / Model
- 5C4129
- Catalog Number
- 5C4129
- Company Name
- BAXTER INTERNATIONAL INC.
- Labeler DUNS
- 005146311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d45e3ef9-955b-4a4a-8801-6d4e7a8bcaa7
Device Description
This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDJ | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35944 | Peritoneal dialysis catheter adaptor, single-use | A connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50085412007408 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 00085412007403 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature