BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 00763000180904 · Model: PA97000 · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: NA
Primary DI: 00763000180904
Version / Model: PA97000
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-06-21
Public Version: 1
Public Version Date: 2020-06-29
Public Version Status: New
Public Device Record Key: e06ce4cc-b61b-4d0f-83a5-022cee5406f7

Device Description

ACTV PA97000 USA

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: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: No
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
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61438	Cardiac pulse generator reader, home-use	An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. This is a home-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000180904	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190574	000

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: -13 – 140 Degrees Fahrenheit
Type: Storage Environment Humidity
Temperature Range: 15 – 90 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 59 – 86 Degrees Fahrenheit