AccessGUDID - DEVICE: CardioMessenger (04035479139360)

GUDID

Device Identifier (DI) Information

Brand Name: CardioMessenger
Version or Model: Smart 3G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401831
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479139360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *Terms of Use

Device Description: No description.

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?
60106	Patient monitoring modem	A portable adaptor/modem intended to connect an electronic device that monitors a patient’s physiologic parameters (e.g., an active-implantable-device communicator that receives signals from an implanted pulse generator such as a cardiac pacemaker) to an analogue telephone line, to send digital information from the monitoring device to a healthcare facility transtelephonically. It typically consists of a small housing with a telephone line socket and a patient monitor connection lead. This device may be used in cases when a patient monitor capable of sending patient data via a mobile telephone (cellular) network has no signal.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OSR	Pacemaker/icd/crt non-implanted components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d66e0ce-7f22-4c61-80bf-a88ac22002ec
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 03, 2016

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(888)345-0374
Email: jon.brumbaugh@biotronik.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES