AccessGUDID - DEVICE: NA (00763000060428)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 24967
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000060428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: RF HEAD 24967 FRU US PATIENT CONN

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61439	Cardiac pulse generator reader, professional	An external device intended to enable a healthcare professional in a clinical setting to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to obtain 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSR	Pacemaker/icd/crt non-implanted components
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
NVZ	Pulse generator, permanent, implantable
DSI	DETECTOR AND ALARM, ARRHYTHMIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163460	000
P890003	386
P890003	406

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac0cf740-ae01-4a4e-8b36-23e338ebdeb4
Public Version Date: January 10, 2025
Public Version Number: 4
DI Record Publish Date: December 16, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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