FDA UDI
In Commercial Distribution
🇺🇸 United States
RELIANCE
DI: 00724995229504
·
Model: Reliance 6500
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RELIANCE
- Primary DI
- 00724995229504
- Version / Model
- Reliance 6500
- Catalog Number
- REL650012MU
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 828222781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-02
- Public Version
- 1
- Public Version Date
- 2024-10-10
- Public Version Status
- New
- Public Device Record Key
- 14b57082-ac3f-480f-8b8e-ce4a208d83de
Device Description
RELIANCE 6500 Series HEPA Filter Drying Cabinet, 12 Scope Main Unit is designed to help you manage access to your endoscope inventory, track key parameters, and easily access vertically hanging endoscopes, all in an organized and controlled drying environment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PUP | Endoscope maintenance system | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45635 | Endoscope drying/storage cabinet | An electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37º Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995229504 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]