BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

ARROW

DI: 60801902124342 · Model: IPN036476 · TELEFLEX INCORPORATED

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: ARROW
Primary DI: 60801902124342
Version / Model: IPN036476
Catalog Number: AK-42703-P1A
Company Name: TELEFLEX INCORPORATED
Labeler DUNS: 002348191
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-10-25
Public Version: 6
Public Version Date: 2022-12-21
Public Version Status: Update
Public Device Record Key: d5e65e5c-75a6-436a-af44-b20be3af95d0

Device Description

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit

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: Yes
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: 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
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50801902124345	GS1	Case	5	Not in Commercial Distribution	2022-12-19
Primary	60801902124342	GS1

Customer Contacts

Phone: +1(919)544-8000
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K071538	000

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store between 20 - 25°C (68 - 77°F).
Type: Storage Environment Temperature
Temperature Range: 20 – 25 Degrees Celsius