FDA.reportPublic FDA data

Mobility+ Enteral Feeding Device 700 mm

Primary DI
05391537090134
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
OTC
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2
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

Regulatory Flags#

DUNS number
985605545
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
05391537090172Mobility+ Enteral Feeding Device 700 mmMOB2-0700MOB2-0700-30, MOB2-0700-03, MOB2-0700-03-09, 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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