AccessGUDID - DEVICE: TRANSFORM (07613327004472)

GUDID

Device Identifier (DI) Information

Brand Name: TRANSFORM
Version or Model: M003SRC05150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRC0515
Company Name: Stryker Corporation

Primary DI Number: 07613327004472
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042405446 *Terms of Use

Device Description: C Compliant Occlusion Balloon Catheter

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:	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Intravascular occluding catheter, image-guided	A sterile flexible tube with an inflatable balloon(s) at the distal end intended to be introduced under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and neurovasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. It is intended for short-term use only. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Intravascular occluding catheter, image-guided

A sterile flexible tube with an inflatable balloon(s) at the distal end intended to be introduced under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and neurovasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. It is intended for short-term use only. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
MJN	Catheter, intravascular occluding, temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122576	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in cool, dry, dark place.

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Balloon Outer Diameter: 5.0 Millimeter
Length: 15.0 Millimeter

Device Record Status

Public Device Record Key: c80325aa-9389-48ec-9f55-5edfec18b417
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016