FDA UDI
In Commercial Distribution
🇺🇸 United States
Ch24 round silicone catheter
DI: M640R99000990011
·
Model: 001
·
RAND SPA
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Ch24 round silicone catheter
- Primary DI
- M640R99000990011
- Version / Model
- 001
- Catalog Number
- R9900099
- Company Name
- RAND SPA
- Labeler DUNS
- 655010531
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-20
- Public Version
- 3
- Public Version Date
- 2022-06-22
- Public Version Status
- Update
- Public Device Record Key
- fde83105-138f-47d1-93c8-7c2c5b447bf1
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
- Yes
- 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 |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47796 | Multi-purpose percutaneous abdominothoracic drainage catheter | A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M640R99000990012 | HIBCC | Unit of sale box | 10 | In Commercial Distribution | |
| Primary | M640R99000990011 | HIBCC | ||||
| Package | M640R99000990013 | HIBCC | Shipping box | 4 | Not in Commercial Distribution | 2022-04-08 |
| Package | M640R99000990014 | HIBCC | Shipping box | 2 | Not in Commercial Distribution | 2022-04-08 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 600 | Millimeter | |
| Catheter Gauge | 24 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius