FDA.reportPublic FDA data

AVANOS

Primary DI
10350770461011
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
43-4100
Catalog number
43-4100
Device description
FARRELL* Valve Closed Enteral Decompression System
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10350770461011PackageGS130In Commercial Distribution
00350770461014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077046101110350770461011
00350770461014003507704610143507704610140350770461014

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
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
true
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
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

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