AccessGUDID - DEVICE: ivWatch Patient Monitor (00814088020009)

GUDID

Device Identifier (DI) Information

Brand Name: ivWatch Patient Monitor
Version or Model: Model 400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00814088020009
Company Name: IVWATCH, LLC

Primary DI Number: 00814088020009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057028415 *Terms of Use

Device Description: A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events

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?
62254	Intravenous access site infiltration/extravasation monitoring system monitor	A portable mains (AC-powered) device intended to be used during intravenous fluid administration to detect and alert healthcare professionals to infiltration/extravasation (leaking of fluid into the surrounding tissues). It includes a display, light source, and a light sensor. Light [visible/near infrared (NIR)] from the monitor is directed to the skin surface near the IV access site, and reflected light from the tissues is directed back to the sensor in the monitor, via a dedicated fibreoptic cable (not included); the monitor is intended to detect changes in reflected light which are processed to indicate fluid leakage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMS	Peripheral Intravenous (Piv) Infiltration Monitor

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
Weight: 2.5 Pound
Depth: 2.63 Inch
Width: 6.14 Inch
Length: 8.0 Inch

Device Record Status

Public Device Record Key: 39e67d5f-33c3-4185-8235-7dbbc5a2fc81
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: September 14, 2016