AccessGUDID - DEVICE: ivWatch Sensor Cable (00814088020047)

GUDID

Device Identifier (DI) Information

Brand Name: ivWatch Sensor Cable
Version or Model: Model 400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IVWATCH, LLC

Primary DI Number: 00814088020047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057028415 *Terms of Use

Device Description: Reusable fiber optic sensor cable for the ivWatch Model 400.

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?
62253	Intravenous access site monitoring system fibreoptic cable, reusable	A noninvasive fibreoptic cord with a distal tip designed for bidirectional transmission of light between an intravenous access monitoring system monitor and the site of peripheral intravenous (IV) infusion during monitoring of infiltration/extravasation (leaking of fluid into the surrounding tissues) and/or line-disconnection. The cable directs light [visible/near infrared (NIR)] from the monitor to the skin surface, and reflected light from the tissues back to the monitor; changes in reflected light are processed to monitor for internal fluid leakage (infiltration/extravasation) and/or external bleeding (associated with line-disconnection). This is a reusable device.	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
Length: 118.1 Inch

Device Record Status

Public Device Record Key: c40d5a40-4b9d-4b6f-9290-c9522411d04b
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: September 14, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20814088020041	10	00814088020047	In Commercial Distribution	Box
10814088020044	5	00814088020047	In Commercial Distribution	Box
30814088020048	10	00814088020047	In Commercial Distribution	Box
40814088020045	40	30814088020048	In Commercial Distribution	Case
50814088020042	40	30814088020048	In Commercial Distribution	Case

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 757-705-2461
Email: chuck.egress@ivwatch.com

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