AccessGUDID - DEVICE: Cook-Swartz (00827002213630)

GUDID

Device Identifier (DI) Information

Brand Name: Cook-Swartz
Version or Model: G21363
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DP-SDP001
Company Name: Cook Vandergrift Inc.

Primary DI Number: 00827002213630
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056867526 *Terms of Use

Device Description: Cook-Swartz Doppler Flow Probe Standard Cuff

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?
18673	Blood flowmeter catheter, Doppler	A device that is a flexible tube designed for insertion within the blood vessels for the purpose of determining blood-flow velocity by measuring the ultrasonic frequency shift between the transmitted and reflected signals (Doppler principle). It typically has a ceramic crystal attached at or near its distal tip that is capable of both transmitting and receiving ultrasound signals [20 megahertz (MHz) frequency is typical]. The proximal end is connected to a Doppler blood flowmeter unit where the measurements are displayed. It is typically used for measurement of the coronary haemodynamics (e.g., blood mean and peak velocity) during coronary procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place. Temperature limits to which the medical device can be safely exposed is -40 to +60 degrees Celsius. Humidity limitation - Non-condensing environment.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b78d9620-47b7-48af-82e7-a5af91095a53
Public Version Date: October 08, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 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
10827002213637	1	00827002213630		In Commercial Distribution	BX

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(812)330-5494
Email: sharedservices@cookmedical.com

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