AccessGUDID - DEVICE: Rocket (05055270914712)

GUDID

Device Identifier (DI) Information

Brand Name: Rocket
Version or Model: R57679
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R57679
Company Name: ROCKET MEDICAL PLC

Primary DI Number: 05055270914712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544313588 *Terms of Use

Device Description: Rocket Filter Set - Cook KMAR Pumps

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
16779	Suction/irrigation tubing, single-use	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
Length: 250.0 Centimeter

Device Record Status

Public Device Record Key: 13f538c5-c12e-4c8a-a83a-1adc2a4c1e05
Public Version Date: June 08, 2021
Public Version Number: 5
DI Record Publish Date: January 17, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05055270957504	10	05055270914712		In Commercial Distribution	Box

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4401914196988
Email: gudid@rocketmedical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES