FDA UDI
In Commercial Distribution
🇺🇸 United States
Cycler Drainage Bag
DI: 00085412007410
·
Model: 5C4145P
·
BAXTER INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Cycler Drainage Bag
- Primary DI
- 00085412007410
- Version / Model
- 5C4145P
- Catalog Number
- 5C4145P
- Company Name
- BAXTER INTERNATIONAL INC.
- Labeler DUNS
- 005146311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6f94c06a-3081-4e4c-8daf-56c3f542f63e
Device Description
This product is to be used with Baxter APD Sets with Cassette. Baxter Manifold Sets and Extension Sets may also be used. Consult instructions for use.
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
- Yes
- 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 | 50085412007415 | GS1 | CASE | 30 | In Commercial Distribution | |
| Primary | 00085412007410 | GS1 | ||||
| Unit of Use | 90085412007413 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K791899 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 15 | Liter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature