AccessGUDID - DEVICE: RxCrush (00850006611126)

GUDID

Device Identifier (DI) Information

Brand Name: RxCrush
Version or Model: EL02-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EL02
Company Name: RESOLVE DESIGNS LLC

Primary DI Number: 00850006611126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 091290281 *Terms of Use

Device Description: Female ENFit to Female Luer Lock Adapter - Screw-on. Connects male ENFit (e.g. RxCrush Pouch) to male Luer syringe.

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):	Yes
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?
64470	ENFit/Luer linear connector	A small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a Luer connection (either lock or slip) at the other end, intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with ENFit connection with another device that has Luer connection. It does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYX	Dispenser, Liquid Medication

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep out of sunlight. Keep out of moisture.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ffe1dcd-e8a1-41b3-bc72-141f9924cf17
Public Version Date: December 25, 2024
Public Version Number: 1
DI Record Publish Date: December 17, 2024