AccessGUDID - DEVICE: Mobility+ OTC Enteral Feeding Device 440 mm (05391537090127)

GUDID

Device Identifier (DI) Information

Brand Name: Mobility+ OTC Enteral Feeding Device 440 mm
Version or Model: MOB2-0440
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-0440-10, MOB2-0440-10-03
Company Name: ROCKFIELD MEDICAL DEVICES LIMITED

Primary DI Number: 05391537090127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985605545 *Terms of Use

Device Description: The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver commercially available liquid nutrition formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in the clinical or home care settings.

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":	Yes
For Single-Use:	No
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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64461	Enteral feeding noninvasive-component set	A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIF	Gastrointestinal Tubes With Enteral Specific Connectors
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233034	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 440 Millimeter

Device Record Status

Public Device Record Key: 8e532d26-be87-48c8-8934-a2443767b2db
Public Version Date: July 11, 2024
Public Version Number: 1
DI Record Publish Date: July 03, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05391537090165	30	05391537090127	In Commercial Distribution	Case
05391537090202	3	05391537090127	In Commercial Distribution	Pack
05391537090240	9	05391537090202	In Commercial Distribution	Case
05391537090288	10	05391537090127	In Commercial Distribution	Pack
05391537090325	3	05391537090288	In Commercial Distribution	Case