FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthrex®
DI: 00888867039032
·
Model: AR-6220
·
ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Arthrex®
- Primary DI
- 00888867039032
- Version / Model
- AR-6220
- Catalog Number
- AR-6220
- Company Name
- ARTHREX, INC.
- Labeler DUNS
- 131747628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-15
- Public Version
- 20
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 4fc7ac17-e3eb-4216-a1ce-2357014e2854
Device Description
TUBING, EXTENSION 6FT. (20-BOX)
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
- No
- 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 |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44772 | Cardiac ablation system irrigation tubing set | A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888867039032 | GS1 | ||||
| Secondary | M150AR62201 | HIBCC | ||||
| Package | 10888867039039 | GS1 | Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)934-4404
- [email protected]