AccessGUDID - DEVICE: TRAP CAPtain™ (00884450278734)

GUDID

Device Identifier (DI) Information

Brand Name: TRAP CAPtain™
Version or Model: 00884450278734
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC80
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450278734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
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):	No
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?
42891	General-purpose bowl, single-use	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	TRAP, STERILE SPECIMEN

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: Volume-80 mL

Device Record Status

Public Device Record Key: 82cbfc08-5ec6-4664-8ab3-a9e93ef60e50
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: March 12, 2019