AccessGUDID - DEVICE: CTM-400 (00816396022171)

GUDID

Device Identifier (DI) Information

Brand Name: CTM-400
Version or Model: 3310-00-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3310-00-01
Company Name: IVY BIOMEDICAL SYSTEMS, INC.

Primary DI Number: 00816396022171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 109132019 *Terms of Use

Device Description: Cardiac Gating Module

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40745	X-ray system synchronizer	A physiological monitoring unit used as a component of a diagnostic x-ray system, e.g., fluoroscopy, angiography or general-purpose, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic diagnostic x-ray applications. It is sometimes referred to as a gated imaging accessory or trigger.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXO	Synchronizer, Ecg/Respirator, Radiographic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Weight: 1.25 Pound
Depth: 11 Inch
Width: 4 Inch
Height: 2 Inch

Device Record Status

Public Device Record Key: 31c6e524-0aa0-4587-8de1-7439607e2ac7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 10, 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: 203-481-4183
Email: sales@ivybiomedical.com

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