FDA.report

Farrell® -Valve Enteral Gastric Pressure Relief System

Primary DI
20815149021984
Brand
Farrell® -Valve Enteral Gastric Pressure Relief System
Company
CORPAK MEDSYSTEMS, INC.
Model
20-4100
Catalog number
20-4100
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
2016-08-04
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

Related Records

Contact Domains

Product Codes

CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20815149021984PackageGS130In Commercial Distribution
10815149021987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2081514902198420815149021984
1081514902198710815149021987

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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

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20815149024442CORFLO cuBBy35-901235-90122016-08-04
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