ivWatch SmartTouch Sensor

Primary DI: 20814088020591
Brand: ivWatch SmartTouch Sensor
Company: IVWATCH, LLC
Model: Model 400
Catalog number: 00814088020597
Device description: Disposable, Electronic Sensor
Published: 2020-07-17
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: MR Unsafe
Rx: true
OTC: false
Sterile: true
Single use: true

Product Codes#

Code, Name table
Code	Name
PMS	Peripheral Intravenous (Piv) Infiltration Monitor

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K192385	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K192385	000	ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable	Ivwatch, LLC	2020-07-02	PMS

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
20814088020591	Package	GS1	80	In Commercial Distribution
00814088020597	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
20814088020591	20814088020591
00814088020597	00814088020597	814088020597	0814088020597

GMDN Terms#

Term, Definition table
Term	Definition
Intravenous access site infiltration/extravasation monitoring system sensor	A noninvasive, electronic component of an infiltration/extravasation monitoring system intended to emit and receive light to/from the skin surface and transmit electronic signals to the system monitor (not included), for the detection of a fluid leak into surrounding tissues at the site of a peripheral intravenous (IV) infusion. It includes an LED light source, photo detector, with an attached electrical cable. This is a single-use device.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Length	18	Inch
Weight	0.03	Pound

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 057028415
Device count: 1
DM exempt: true
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00814088020597	ivWatch SmartTouch Sensor	Model 400	00814088020597	2020-07-17
00814088020115	ivWatch Patient Cable	Model 400	00814088020115	2020-07-17
00814088020122	ivWatch Extension Module	Model 400	00814088020122	2020-07-17
00814088020726	blox	BLX-9501		2021-11-11
00814088020788	blox	BLX-9501		2021-11-11
00814088020382	ivWatch Patient Monitor	Model 400	00814088020382	2019-03-19
00814088020009	ivWatch Patient Monitor	Model 400	00814088020009	2016-09-14
00814088020016	ivWatch Sensor Receptacle	Model 400		2016-09-14
00814088020047	ivWatch Sensor Cable	Model 400		2016-09-14
00814088020092	ivWatch Patient Monitor	Model 400	00814088020092	2017-07-11

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00814088020597	ivWatch SmartTouch Sensor	IVWATCH, LLC	PMS	2020-07-17
00814088020115	ivWatch Patient Cable	IVWATCH, LLC	PMS	2020-07-17
00814088020122	ivWatch Extension Module	IVWATCH, LLC	PMS	2020-07-17
00814088020382	ivWatch Patient Monitor	IVWATCH, LLC	PMS	2019-03-19
00814088020092	ivWatch Patient Monitor	IVWATCH, LLC	PMS	2017-07-11
00814088020009	ivWatch Patient Monitor	IVWATCH, LLC	PMS	2016-09-14
00814088020016	ivWatch Sensor Receptacle	IVWATCH, LLC	PMS	2016-09-14
00814088020047	ivWatch Sensor Cable	IVWATCH, LLC	PMS	2016-09-14