AccessGUDID - DEVICE: RENPHO BLOOD PRESSURE MONITOR (00860002249681)

GUDID

Device Identifier (DI) Information

Brand Name: RENPHO BLOOD PRESSURE MONITOR
Version or Model: RP-BPM004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JOICOM CORPORATION

Primary DI Number: 00860002249681
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081060692 *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:	No
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?
62805	Transcutaneous central venous pressure sensor	A noninvasive, electronic device intended to transcutaneously detect a patient's central venous pressure (CVP) using light emission/diffusion signals (e.g., near-infrared spectroscopy). It consists of a small photoelectric unit placed on the jugular vein area of the neck, tubing for ambient pressure detection, and a calibration reference. The detected signals correlating to CVP are transmitted to a connected blood pressure monitor (not included) with integrated software for measurement, analysis, and display. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

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: a88d8592-043f-4e81-a253-88c7d855499f
Public Version Date: February 17, 2025
Public Version Number: 2
DI Record Publish Date: July 30, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10860002249688	50	00860002249681		In Commercial Distribution

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

[?]

No Customer Contact currently defined

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