BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Swan Kit

DI: 00886333203031 · Model: 049954502AT · ARGON MEDICAL DEVICES, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Swan Kit
Primary DI: 00886333203031
Version / Model: 049954502AT
Catalog Number: 049954502AT
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: 2016-09-20
Public Version: 5
Public Version Date: 2026-04-17
Public Version Status: Update
Public Device Record Key: f0fd913e-c9ba-48da-8c03-77ac9153e006
Distribution End Date: 2024-12-10

Device Description

Swan Kit

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: 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
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	870.2850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45275	Invasive blood pressure transducer set	A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333203035	GS1	Box	10	Not in Commercial Distribution	2024-12-10
Primary	00886333203031	GS1

Customer Contacts

Phone: 1.800.927.4669
Email: [email protected]