FDA.reportPublic FDA data

Farrell® -Valve Enteral Gastric Pressure Relief System

Primary DI
20815149021977
Brand
Farrell® -Valve Enteral Gastric Pressure Relief System
Company
CORPAK MEDSYSTEMS, INC.
Model
43-4100
Catalog number
43-4100
Device description
A closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. For use with neonates, pediatric and adult patients.
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815149021977PackageGS130In Commercial Distribution
10815149021970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081514902197720815149021977
1081514902197010815149021970

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum; it is not intended for intravenous (IV) administration. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an enteral feeding set] and is not intended to be directly connected to the invasive feeding tube. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)403-3400questions@corpak.com

Regulatory Flags#

DUNS number
147530323
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815149021147CORGRIP Tube Retention System25-00825-0082016-08-04
10815149021154CORGRIP Tube Retention System25-01025-0102016-08-04
10815149021161CORGRIP Tube Retention System25-01225-0122016-08-04
10815149025442CORGRIP Tube Retention System25-01425-0142017-02-27
10815149025459CORGRIP Tube Retention System25-01625-0162017-02-27
10815149025466CORGRIP Tube Retention System25-01825-0182017-02-27
10815149021734CORFLO Y Extension Set40-100740-10072016-07-28
10815149022861CORFLO cuBBy Decompression Set56-011256-01122016-06-24
10815149022878CORFLO cuBBy Right Angle Feeding Set56-901256-90122016-06-24
10815149022885CORFLO cuBBy Right Angle Feeding Set56-902456-90242016-06-24
10815149024445CORFLO cuBBy35-901235-90122016-08-04
10815149024452CORFLO cuBBy35-902435-90242016-08-04
10815149024469Enteral Y Extension Set20-100720-10072016-08-04
10815149024711CORFLO AIV Enteral Feeding Extension Set20-1030AIV20-1030AIV2016-08-04
10815149024728CORFLO AIV Enteral Feeding Tube Extension Set20-1060AIV20-1060AIV2016-08-04
10815149024735CORFLO AIV Enteral Feeding Extension Set20-1060AIV-S20-1060AIV-S2016-08-04
10815149025268Mapcath stylet60-201160-20112016-08-04
10815149025275Mapcath stylet60-201860-20182016-08-04
20815149021144CORGRIP Tube Retention System25-00825-0082016-08-04
20815149021151CORGRIP Tube Retention System25-01025-0102016-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
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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
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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
05060999351564EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351595EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351625EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351656EnteralGBUK GROUP LIMITEDPIF2025-08-20
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24