AccessGUDID - DEVICE: Mikro-Cath Pressure Catheter (00868924000205)

GUDID

Device Identifier (DI) Information

Brand Name: Mikro-Cath Pressure Catheter
Version or Model: 825-0101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 825-0101
Company Name: MILLAR INC.

Primary DI Number: 00868924000205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058269648 *Terms of Use

Device Description: The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound.

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":	Yes
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?
15071	Catheter-tip transducer, pressure	A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	Transducer, Pressure, Catheter Tip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093111	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 2a5b4aff-2b15-48ba-96d1-97e4d9830d8e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: October 03, 2016