AccessGUDID - DEVICE: ICU Medical (00840619044497)

GUDID

Device Identifier (DI) Information

Brand Name: ICU Medical
Version or Model: 42402-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 424020402
Company Name: ICU MEDICAL, INC.

Primary DI Number: 00840619044497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM WITH 1000 ML WASTE BAG, FLUID ADMINISTRATION SET AND DUAL CHECK VALVE

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":	Yes
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?
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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 [?]
K932141	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 289f70f6-a7a1-46b9-a7f9-9f08a0bddc4b
Public Version Date: September 06, 2021
Public Version Number: 1
DI Record Publish Date: August 29, 2021