AccessGUDID - DEVICE: RHYTHMIA HDx™ (08714729938712)

GUDID

Device Identifier (DI) Information

Brand Name: RHYTHMIA HDx™
Version or Model: M004RH10200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729938712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Signal Station

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?
46250	Transducer signal amplifier	An electronic device that increases current, voltage, or power to intensify the electrical signal sent to or received from a transducer (e.g., electroacoustic, electro-optical, electromechanical), sometimes providing impedance matching. It will provide an electrical interface between a physiological transducer and a patient monitor or patient monitoring system that is used to monitor pressures such as, noninvasive and invasive blood pressure, oesophageal pressures, urinary tract pressures, intrauterine pressures and intraocular pressures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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: e562a8ba-19ff-40df-86fc-941589884a5c
Public Version Date: October 02, 2024
Public Version Number: 5
DI Record Publish Date: May 03, 2017

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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