AccessGUDID - DEVICE: MEDRAD XDS Extravasation Detection System (00616258008172)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD XDS Extravasation Detection System
Version or Model: XDS 700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XDS 700
Company Name: BAYER MEDICAL CARE INC.

Primary DI Number: 00616258008172
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058716649 *Terms of Use

Device Description: "CT - EXTRAVASATION DETECTOR SYS,NON CE (60727064)"

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?
57999	CT contrast medium injection system, line-powered, mobile	An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for CT studies, and is mobile (e.g., on a wheeled pedestal). The system may synchronize media delivery with the x-ray generator during CT scanning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZQ	Injector, Contrast Medium, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063090	000

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: 6f032c96-0072-4914-a380-d11e3cce4a59
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016