AccessGUDID - DEVICE: ICU Medical (00840619046422)

GUDID

Device Identifier (DI) Information

Brand Name: ICU Medical
Version or Model: 41406-23
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 414060423
Company Name: ICU MEDICAL, INC.

Primary DI Number: 00840619046422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: Central Venous Catheter, Heparin Coated, 2 Lumen, 16/16 G, 20 cm, PMAP, Expanded Kit

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:	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?
10729	Centrally-inserted central venous catheter	A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DQE	Catheter, oximeter, fiber-optic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091268	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: 397fe06e-4ffc-4417-b6d5-ea1c80d365f0
Public Version Date: September 06, 2021
Public Version Number: 1
DI Record Publish Date: August 29, 2021