FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 10192253042863
·
Model: 8888271007
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 10192253042863
- Version / Model
- 8888271007
- Catalog Number
- 8888271007
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-27
- Public Version
- 1
- Public Version Date
- 2025-03-07
- Public Version Status
- New
- Public Device Record Key
- f0721a6d-e564-486a-8141-88c9f15eb3a4
Device Description
5-in-1 Bubble Connector Vinyl 3/16 - 7/16 in. (5 - 11 mm)
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCD | CONNECTOR, CATHETER | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64696 | Non-ISO80369-standardized small-bore multichannel connector, single-use | A small, non-powered, noninvasive, small-bore tubular connector with three or more connections (typically barbed, bayonet, conical, threaded and/or non-Luer-slip), none of which are designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), intended to connect three or more luminal devices (e.g., tubing, container) with each other during a medical procedure. It is typically T-, Y- or cross-shaped; it does not incorporate a filter, valve, clamp, tubing or puncturing component, and is not a dedicated gas-line connector. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253042861 | GS1 | CASE | 100 | In Commercial Distribution | |
| Primary | 10192253042863 | GS1 |