FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Arterial Line Kit
DI: 00886333215744
·
Model: 498440
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Arterial Line Kit
- Primary DI
- 00886333215744
- Version / Model
- 498440
- Catalog Number
- 498440
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2026-04-17
- Public Version Status
- Update
- Public Device Record Key
- f3cb34f1-d6ac-41f0-8667-934f4137538f
- Distribution End Date
- 2025-01-06
Device Description
Arterial Line Kit 18ga x 6"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65100 | Vascular catheterization support/maintenance kit, medicated | A collection of non-dedicated devices which includes a pharmaceutical agent intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes [in addition to the pharmaceutical agent(s)] devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter nor catheter introduction device are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20886333215748 | GS1 | Box | 10 | Not in Commercial Distribution | 2025-01-06 |
| Primary | 00886333215744 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K780871 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 18ga x 6" |