FDA UDI
In Commercial Distribution
🇺🇸 United States
MINICAP EXTENDED LIFE PD TRNS
DI: 00085412841625
·
Model: 5C4482A
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- MINICAP EXTENDED LIFE PD TRNS
- Primary DI
- 00085412841625
- Version / Model
- 5C4482A
- Catalog Number
- 5C4482A
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 005083209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-05
- Public Version
- 1
- Public Version Date
- 2024-08-13
- Public Version Status
- New
- Public Device Record Key
- 06eb95e7-e8c5-44c2-8e58-de623f4cd32d
Device Description
This set consists of a female locking connector/on-off clamp assembly, tubing and double sealing male Luer lock connector. This set is to be used with the Baxter Locking Titanium Adapter for Peritoneal Dialysis Catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
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 |
|---|---|---|---|---|
| 35000 | Peritoneal dialysis system tubing set | A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20085412841629 | GS1 | Pack | 6 | In Commercial Distribution | |
| Primary | 00085412841625 | GS1 | ||||
| Package | 50085412841620 | GS1 | Case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature