FDA UDI
In Commercial Distribution
🇺🇸 United States
PleurX
DI: 10885403231520
·
Model: 50-7700
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- PleurX
- Primary DI
- 10885403231520
- Version / Model
- 50-7700
- Catalog Number
- 50-7700
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-15
- Public Version
- 6
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 9194a504-e76a-4217-b601-33f109f2be3f
Device Description
PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home Use
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47797 | Pleural/peritoneal drainage catheterization kit, non-medicated | A collection of non-powered devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions (e.g., haemothorax, empyema, ascites), other fluids, and/or air; some types are additionally intended for infusion of fluids/materials into the pleural/peritoneal space. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller), non-dedicated catheterization support devices (e.g., dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403231528 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 10885403231520 | GS1 | ||||
| Package | 20885403231527 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1000 | Milliliter | |
| Catheter Gauge | 15.5 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius