AccessGUDID - DEVICE: ICU Medical (00840619030094)

GUDID

Device Identifier (DI) Information

Brand Name: ICU Medical
Version or Model: 50458-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50458-01
Company Name: ICU MEDICAL, INC.

Primary DI Number: 00840619030094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated, Basic 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:	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?
36218	Pulmonary artery balloon catheter, oximetric	A flexible tube with an inflatable balloon at its distal tip designed for measuring pulmonary arterial pressures and mixed venous oxygen saturation (SvO2) levels when connected to an appropriate oximetric patient monitor; it may also measure pulmonary artery wedge pressure. It uses a fibreoptic bundle and light-emitting diodes (LEDs) which using light emitted at two or three different wavelengths (e.g., red or near infrared) from the catheter and reflected back from the red blood cells provide the measurements. It is used in emergencies, for monitoring critically ill patients (e.g., acute respiratory failure, severe head injury) and during surgical procedures. This is a single-use device.	Active	false

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: dde6bcc1-6a11-4ded-8cc1-18ed1f9fab13
Public Version Date: October 12, 2022
Public Version Number: 1
DI Record Publish Date: October 04, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10840619030091	4	00840619030094		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)829-9025
Email: customerservice@icumed.com

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