AccessGUDID - DEVICE: CLEARSIGHT (00690103193367)

GUDID

Device Identifier (DI) Information

Brand Name: CLEARSIGHT
Version or Model: CSCL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CSCL
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103193367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: CLEARSIGHT FINGER CUFF LARGE MULTI PACK

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:	Yes
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?
37326	Blood pressure cuff, single-use	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.	Active	false
43267	Patient positioning sensor	A device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
DSB	PLETHYSMOGRAPH, IMPEDANCE
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140312	000
K160552	000

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
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: LARGE

Device Record Status

Public Device Record Key: a17f1b36-fbd9-4423-aef4-3a564347e8e4
Public Version Date: December 19, 2018
Public Version Number: 4
DI Record Publish Date: September 03, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20690103193361	5	00690103193367		In Commercial Distribution	Shipper
50690103193362	5	00690103193367		In Commercial Distribution	Shipper

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

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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