FDA UDI
In Commercial Distribution
🇺🇸 United States
PleurX
DI: 10885403185694
·
Model: 50-7280
·
CAREFUSION 2200, INC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PleurX
- Primary DI
- 10885403185694
- Version / Model
- 50-7280
- Catalog Number
- 50-7280
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-12
- Public Version
- 4
- Public Version Date
- 2023-08-01
- Public Version Status
- Update
- Public Device Record Key
- fb28bd55-3a4c-4040-89c6-a66ac044dc83
Device Description
PleurX Catheter Access Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | Cardiovascular | 870.5050 | 2 |
| PNG | Peritoneal, drainage catheter for refractory ascites, long-term indwelling | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64112 | Pleural catheter syringe-infusion set | A collection of devices intended to be used in conjunction with a pleural drainage catheter (not included) to manually infuse pharmaceutical agents (e.g., sclerosing agent) [not included] into the pleural cavity, and for catheter flushing/maintenance; it may in addition be intended for manual aspiration of fluids. It includes a catheter/syringe needless valve connector with a syringe and typically additional supportive devices (e.g., clamps, wipes/dressings); it does not include any powered pumps or pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403185692 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 10885403185694 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]