FDA.reportPublic FDA data

Mobility+ Enteral Feeding Device 700 mm

Primary DI
05391537090172
Brand
Mobility+ Enteral Feeding Device 700 mm
Company
ROCKFIELD MEDICAL DEVICES LIMITED
Model
MOB2-0700
Catalog number
MOB2-0700-30, MOB2-0700-03, MOB2-0700-03-09, MOB2-
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.
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233034000Mobility+ Enteral Feeding System OTCRockfield Medical2024-04-12PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391537090172PackageGS130In Commercial Distribution
05391537090219PackageGS13In Commercial Distribution
05391537090257PackageGS19In Commercial Distribution
05391537090295PackageGS110In Commercial Distribution
05391537090332PackageGS13In Commercial Distribution
05391537090134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391537090172053915370901725391537090172
05391537090219053915370902195391537090219
05391537090257053915370902575391537090257
05391537090295053915370902955391537090295
05391537090332053915370903325391537090332
05391537090134053915370901345391537090134

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding noninvasive-component setA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length700Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985605545
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391537090080Mobility+ Enteral Feeding Device Bag PurplePN2001-012024-07-03
05391537090097Mobility+ Enteral Feeding Device Bag BlackPN2001-022024-07-03
05391537090127Mobility+ OTC Enteral Feeding Device 440 mmMOB2-0440MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-2024-07-03
05391537090134Mobility+ Enteral Feeding Device 700 mmMOB2-0700MOB2-0700-30, MOB2-0700-03, MOB2-0700-03-09, MOB2-2024-07-03
05391537090141Mobility+ Enteral Feeding Device 1000 mmMOB2-1000MOB2-1000-30, MOB2-1000-03, MOB2-1000-03-09, MOB2-2024-07-03
05391537090158Mobility+ Enteral Feeding Device 1900 mmMOB2-1900MOB2-1900-30, MOB2-1900-03,MOB2-1900-03-09, MOB2-12024-07-03
05391537090103Mobility+ Enteral Feeding Device Bag PurplePN2001-012024-07-03
05391537090110Mobility+ Enteral Feeding Device Bag BlackPN2001-022024-07-03
05391537090165Mobility+ OTC Enteral Feeding Device 440 mmMOB2-0440MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-2024-07-03
05391537090189Mobility+ Enteral Feeding Device 1000 mmMOB2-1000MOB2-1000-30, MOB2-1000-03, MOB2-1000-03-09, MOB2-2024-07-03
05391537090196Mobility+ Enteral Feeding Device 1900 mmMOB2-1900MOB2-1900-30, MOB2-1900-03,MOB2-1900-03-09, MOB2-12024-07-03
05391537090004Mobility+ Enteral Feeding Device 440 mmMOB1-4402023-02-16
05391537090011Mobility+ Enteral Feeding Device 700 mmMOB1-7002023-02-16
05391537090028Mobility+ Enteral Feeding Device 1000 mmMOB1-10002023-02-16
05391537090035Mobility+ Enteral Feeding Device 1900 mmMOB1-19002023-02-16

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