FDA UDI
In Commercial Distribution
🇺🇸 United States
MD Resource
DI: 00859898006157
·
Model: Softube
·
MEDICAL DEVICE RESOURCE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- MD Resource
- Primary DI
- 00859898006157
- Version / Model
- Softube
- Catalog Number
- Softube
- Company Name
- MEDICAL DEVICE RESOURCE CORPORATION
- Labeler DUNS
- 126830020
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 43dd6ae6-3b1f-4e24-b043-408ca5e1c300
Device Description
Softube - Infiltration Disposable Tubing
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
- 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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10730 | Irrigation catheter, single-lumen | A flexible tube used to introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00859898006171 | GS1 | 6 | In Commercial Distribution | ||
| Package | 00859898006164 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00859898006157 | GS1 | ||||
| Package | 00859898006362 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 510-732-9950
- [email protected]