FDA UDI
In Commercial Distribution
🇺🇸 United States
Xen Enzymatic+ 5G
DI: 05060478112112
·
Model: XV1755/19NA
·
QUADRALENE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xen Enzymatic+ 5G
- Primary DI
- 05060478112112
- Version / Model
- XV1755/19NA
- Catalog Number
- 6036003001
- Company Name
- QUADRALENE LIMITED
- Labeler DUNS
- 218111037
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-25
- Public Version
- 1
- Public Version Date
- 2025-08-04
- Public Version Status
- New
- Public Device Record Key
- a54453c3-6e06-44a9-acf2-fa1baea84a69
Device Description
A neutral pH, low-foaming, quadruple enzyme detergent for cleaning medical instruments and devices, including flexible endoscopes, using manual methods, ultrasonic, automated washer-disinfectors, including cart washers.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | 880.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63385 | Medical device cleaning agent | A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060478112112 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit