FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 20884527004680
·
Model: 43311
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 20884527004680
- Version / Model
- 43311
- Catalog Number
- 43311
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 10
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- 9492fb5a-10ce-4544-a9be-de16d50016d7
Device Description
Peripheral Inserted Central Catheter (PICC) Insertion Tray,Dual Lumen
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWL | Peripheral Catheter Insertion Kit | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64573 | Peripheral intravenous catheterization kit | A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30884527004687 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 20884527004680 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Centimeter | |
| Catheter Gauge | 1.9 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;