FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SCOPE BUDDY TUBING
DI: 00677964055140
·
Model: SB-110-HU1001
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SCOPE BUDDY TUBING
- Primary DI
- 00677964055140
- Version / Model
- SB-110-HU1001
- Catalog Number
- SB110HU1001
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-10
- Public Version
- 9
- Public Version Date
- 2023-08-09
- Public Version Status
- Update
- Public Device Record Key
- d509cfa5-8f79-4ab1-b174-8ea241b2e604
- Distribution End Date
- 2023-08-08
Device Description
Scope Buddy Tubing for Olympus
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60417 | Luer/non-ISO80369-standardized linear connector, reusable | A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00677964055140 | GS1 | ||||
| Package | 10677964015547 | GS1 | Box | 10 | Not in Commercial Distribution | 2023-08-08 |
| Package | 20677964055144 | GS1 | Case | 30 | Not in Commercial Distribution | 2023-08-08 |
Customer Contacts
- Phone
- +1(800)444-4729
- [email protected]