ROCKFIELD MEDICAL DEVICES LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3017607339	3017607339	ROCKFIELD MEDICAL DEVICES LTD.	1	N	2026-01-01	ATU iHub Galway Old Dublin Road Galway IE H91 DCH9
3026777381	3026777381	Rockfield Medical Devices Inc	1	Y	2026-01-01	c/o mHUB Chicago 1623 W Fulton Street Chicago IL US 60612

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
313278	1786744530	K233034	Mobility+ Enteral Feeding System OTC	PIF	2024-04-12
313278	1036792343	K222678	Mobility+ Enteral Feeding System	PIF	2022-10-27
313278	1833650283

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PIF	2	2024-04-12

GUDID#

Mobility+ Enteral Feeding Device 1900 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device 1000 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device 700 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ OTC Enteral Feeding Device 440 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device Bag Black - Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Enteral Feeding Device to be worn on the body in a number of configurations.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device Bag Purple - Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Enteral Feeding Device to be worn on the body in a number of configurations.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device 1900 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device 1000 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device 700 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ OTC Enteral Feeding Device 440 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device Bag Black - Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Enteral Feeding Device to be worn on the body in a number of configurations.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device Bag Purple - Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Enteral Feeding Device to be worn on the body in a number of configurations.
ROCKFIELD MEDICAL DEVICES LIMITED
2024-07-03
Mobility+ Enteral Feeding Device 1900 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2023-02-16
Mobility+ Enteral Feeding Device 1000 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2023-02-16
Mobility+ Enteral Feeding Device 700 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2023-02-16
Mobility+ Enteral Feeding Device 440 mm - 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.
ROCKFIELD MEDICAL DEVICES LIMITED
2023-02-16