AccessGUDID - DEVICE: Rocket (05055270913678)

GUDID

Device Identifier (DI) Information

Brand Name: Rocket
Version or Model: R57405
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R57405
Company Name: ROCKET MEDICAL PLC

Primary DI Number: 05055270913678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544313588 *Terms of Use

Device Description: Rocket KCH Fetal Bladder Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Closed-wound drainage kit, micro-drainage	A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for atraumatic over-the-wire placement of the catheter. The initial puncture is made with the needle, the guidewire is advanced through the needle, which is then removed, and the catheter/dilator is advanced over the guidewire to obtain access to the site. The kit may have a wide range of surgical applications (e.g., general and plastic surgery). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Closed-wound drainage kit, micro-drainage

A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for atraumatic over-the-wire placement of the catheter. The initial puncture is made with the needle, the guidewire is advanced through the needle, which is then removed, and the catheter/dilator is advanced over the guidewire to obtain access to the site. The kit may have a wide range of surgical applications (e.g., general and plastic surgery). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H970001	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

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Storage and Handling
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
Handling Environment Temperature: between -5 and 40 Degrees Celsius
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99c35078-32c0-404f-b747-b05f91db8793
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 2016