Schiller IBP transducer connecting cable

Basic Information

• Brand Name: Schiller IBP transducer connecting cable
• Primary DI: 07613365003628
• Version / Model: 2.310255
• Catalog Number: 2.310255
• Company Name: Schiller AG
• Labeler DUNS: 480868538
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-27
• Public Version: 1
• Public Version Date: 2023-10-05
• Public Version Status: New
• Public Device Record Key: b1c8b609-bde8-4476-a237-c9b29afe6fd1

Device Description

IBP LP 3.7 Utah CC

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613365003628	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221056	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity