AccessGUDID - DEVICE: Juzo Pressure Monitor (00640095290407)

GUDID

Device Identifier (DI) Information

Brand Name: Juzo Pressure Monitor
Version or Model: 9065PM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 29040
Company Name: Julius Zorn, Inc.

Primary DI Number: 00640095290407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123197535 *Terms of Use

Device Description: Juzo Pressure Monitor

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):	Yes
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?
64487	Bandage pressure monitor	A small, wearable, electrically-powered device intended to be placed under a pressure bandage (typically during bandage application) for both initial and continuous measurement of sub-bandage pressure, to help facilitate optimal pressure therapy for disorders such as venous leg ulcers. It includes a pressure sensor, a display, and wireless transmitter, which allow results to be collected/analysed/reported using an off-the-shelf device (e.g., smartphone) with accompanying software. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFC	SYSTEM, PRESSURE MEASUREMENT, INTERMITTENT

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: 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: 21b49205-e45f-4f05-bc95-67a7916c90c3
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 08, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)222-4999
Email: customercare@juzousa.com

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