AccessGUDID - DEVICE: Convey (08714729853138)

GUDID

Device Identifier (DI) Information

Brand Name: Convey
Version or Model: 8F Convey JR4.5 SH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H749392666930
Company Name: PendraCare International B.V.

Primary DI Number: 08714729853138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413008652 *Terms of Use

Device Description: The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.

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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132197	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

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from Sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8F Diameter
Device Size Text, specify: Two (2) Side Holes in Tip Section.
Length: 100 Centimeter

Device Record Status

Public Device Record Key: 33214a07-5bac-4c0a-9299-fae0ac384f23
Public Version Date: December 22, 2021
Public Version Number: 7
DI Record Publish Date: May 01, 2016