AccessGUDID - DEVICE: Angios Classic Angiographic Convenience Kit (00885672101855)

GUDID

Device Identifier (DI) Information

Brand Name: Angios Classic Angiographic Convenience Kit
Version or Model: ANG4-0038
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ANG4-0038
Company Name: Oscor Inc.

Primary DI Number: 00885672101855
Issuing Agency: GS1
Commercial Distribution End Date: May 10, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Angiographic Convenience Kit, 4F

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:	Yes
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?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092118	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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Pigtail Side Holes: 5
Device Size Text, specify: Recommended Pressure Limit: 1200 psi max.
Device Size Text, specify: Guidewire - Length: 150 cm, OD: 0.035 in
Device Size Text, specify: JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
Device Size Text, specify: Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
Device Size Text, specify: Maximum Recommended Guidewire 0.038 in
Device Size Text, specify: Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
Device Size Text, specify: Flow Rate: JR: 18 mL/sec, JL: 19 mL/sec, PT: 19 mL/sec

Device Record Status

Public Device Record Key: d56c5ca1-519d-4c60-942c-a977bd82403f
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: November 16, 2017