AccessGUDID - DEVICE: Rocket (05055270909329)

GUDID

Device Identifier (DI) Information

Brand Name: Rocket
Version or Model: R28410
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R28410
Company Name: ROCKET MEDICAL PLC

Primary DI Number: 05055270909329
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 544313588 *Terms of Use

Device Description: Rocket Tubing Mount Angled

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
37798	Suction system filter, microbial	A screening device intended to be installed within a suction system and which has a membrane pore size small enough to retain bacterial pathogens, thus preventing the environment from becoming infected and decreasing the risk of cross-infection to subsequent patients. It is typically directly connected to the suction system collection bottle/canister, or as a common filter serving more than one bottle/canister through a switching mechanism, or in a tubing line between the suction bottle/canister and the suction pump, or at the suction pump exhaust where driving gases are discarded. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQG	Accessory, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000394	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: 9f4ad25e-6985-4e4e-8495-040ad4b1c38d
Public Version Date: December 08, 2023
Public Version Number: 2
DI Record Publish Date: October 30, 2023