AccessGUDID - DEVICE: Merit Medical Flow Control Switch™ (10884450295165)

GUDID

Device Identifier (DI) Information

Brand Name: Merit Medical Flow Control Switch™
Version or Model: 10884450295165
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 10884450295165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

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:	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?
35375	Stopcock	A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: Pressure Rating (psi/bar)-1200 psi (83 bar)

Device Record Status

Public Device Record Key: 9bae67b7-1562-4e99-ae7c-cb06a38a82d4
Public Version Date: May 12, 2025
Public Version Number: 3
DI Record Publish Date: September 24, 2016