FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 10192253013016
·
Model: 8888750018
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 10192253013016
- Version / Model
- 8888750018
- Catalog Number
- 8888750018
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-26
- Public Version
- 1
- Public Version Date
- 2022-11-03
- Public Version Status
- New
- Public Device Record Key
- 2ed3b33b-3dfb-49d0-863a-0e305ac99ac5
Device Description
True content to be populated as part of rebranding
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDH | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17189 | Gastric lavage system | A device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris (e.g., toxic substances) from the stomach. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated liquid (e.g., saline); an extractor (frequently using vacuum) and controls for liquid temperature/pressure and rate of liquid infusion/withdrawal; and bags for the irrigation solution and waste. Most systems can deliver charcoal to the stomach for absorption of toxic substances; they are mainly used in emergency departments and for cleaning/evacuation of the stomach before some endoscopic and/or surgical procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253013014 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 10192253013016 | GS1 |