FDA.reportPublic FDA data

Mobility+ Enteral Feeding Device 1900 mm

Primary DI
05391537090196
Brand
Mobility+ Enteral Feeding Device 1900 mm
Company
ROCKFIELD MEDICAL DEVICES LIMITED
Model
MOB2-1900
Catalog number
MOB2-1900-30, MOB2-1900-03,MOB2-1900-03-09, MOB2-1
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
05391537090196PackageGS130In Commercial Distribution
05391537090233PackageGS13In Commercial Distribution
05391537090271PackageGS19In Commercial Distribution
05391537090318PackageGS110In Commercial Distribution
05391537090356PackageGS13In Commercial Distribution
05391537090158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391537090196053915370901965391537090196
05391537090233053915370902335391537090233
05391537090271053915370902715391537090271
05391537090318053915370903185391537090318
05391537090356053915370903565391537090356
05391537090158053915370901585391537090158

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
Length1900Millimeter

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253068764CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068771CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068788CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068795CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068801CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068818CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068825CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068832CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253011449CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10850016172485KBMEDKB Medical (group), Inc.PIF2025-05-21
10850016172492KBMEDKB Medical (group), Inc.PIF2025-05-21
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24