AccessGUDID - DEVICE: Accuryn Monitor Mount with Clamp (00850019755237)

GUDID

Device Identifier (DI) Information

Brand Name: Accuryn Monitor Mount with Clamp
Version or Model: FGN-06-100202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGN-06-100202
Company Name: POTRERO MEDICAL, INC.

Primary DI Number: 00850019755237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079428290 *Terms of Use

Device Description: The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
61434	Portable active medical device mount	A device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZL	Catheter, Retention Type, Balloon
PHU	Intra-Abdominal Pressure Monitoring Device
EXY	Uroflowmeter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 7243e354-ebda-4d77-91cf-762d7b35cdc3
Public Version Date: July 25, 2024
Public Version Number: 4
DI Record Publish Date: October 19, 2022