PA 10

Basic Information

• Brand Name: PA 10
• Primary DI: 04035479131609
• Version / Model: 394500
• Catalog Number: 394500
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: be6a8c5c-8ce7-4a76-ace9-001e35908f09

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: 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
NVY	Permanent defibrillator electrodes	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46842	Cardiac pulse generator analyser cable, single-use	An electrical conductor used to connect a pulse generator analyser to the leads of an implantable pulse generator (IPG) [i.e., an implantable pacemaker or automatic implantable cardioverter-defibrillator (AICD)] to test the function of the generator during the implantation procedure. It is typically an assembly of insulated wires (e.g., 2-4 meters in length) that terminate into several leads, each having a connector (e.g., an alligator clip) that connects to the implantable pacing leads (e.g., IS-1 leads) of the pulse generator, and with a connector at the proximal end that connects either directly or via an adaptor to the pulse generator analyser. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479131609	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P980023	057

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 32 – 131 Degrees Fahrenheit