FDA UDI
In Commercial Distribution
🇺🇸 United States
CYGNUS
DI: 00843356102963
·
Model: ASO3E160
·
CYGNUS MEDICAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CYGNUS
- Primary DI
- 00843356102963
- Version / Model
- ASO3E160
- Company Name
- CYGNUS MEDICAL L.L.C.
- Labeler DUNS
- 103169095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-15
- Public Version
- 1
- Public Version Date
- 2026-01-23
- Public Version Status
- New
- Public Device Record Key
- 28a5f9cb-f098-4833-a771-54d60d307ea7
Device Description
ERCP160 SET WITH ONE EACH OF: ASOA3, ASOA5, ASOA6, THREADED CONNECTOR, AND 2.5" SOFT TUBING 100 PER CASE
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JRJ | Unit, Drying | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65046 | Endoscope dryer | An electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843356102963 | GS1 | ||||
| Package | 10843356102960 | GS1 | case | 100 | In Commercial Distribution |