FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 50192253018514
·
Model: 8888270306
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Argyle
- Primary DI
- 50192253018514
- Version / Model
- 8888270306
- Catalog Number
- 8888270306
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-05-07
- Public Version
- 1
- Public Version Date
- 2024-05-15
- Public Version Status
- New
- Public Device Record Key
- 9d1d314f-c3b7-4e27-8323-a152fd94ba86
Device Description
Argyle™ Sims Connector, Vinyl, 3/16" - 7/16" (5 mm - 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
- 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 |
|---|---|---|---|---|
| GAZ | TUBING, NONINVASIVE | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64466 | Non-ISO80369-standardized small-bore linear connector, single-use | A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with connections at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which are not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10192253018516 | GS1 | ||||
| Primary | 50192253018514 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 5 | Millimeter | |
| Outer Diameter | 11 | Millimeter |