FDA.reportPublic FDA data

AVANOS

Primary DI
10350770466412
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
44-4100
Catalog number
44-4100
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
10350770466412PackageGS130In Commercial Distribution
00350770466415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077046641210350770466412
00350770466415003507704664153507704664150350770466415

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
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
10193494001695PROBLOC* II Insulated Regional Block Needle120008760HN3S-1002025-12-08
10193494001701PROBLOC* II Insulated Regional Block Needle120008761HN3S-1502025-12-08
10193494001718PROBLOC* II Insulated Regional Block Needle120008762HN3S-402025-12-08
10193494001725PROBLOC* II Insulated Regional Block Needle120008763HN3S-802025-12-08
10193494001732PROBLOC* II Insulated Regional block Needle120008753HN1-402025-11-28
10193494001749PROBLOC* II Insulated Regional block Needle120008754HN1-802025-11-28
10193494001756PROBLOC* II Insulated Regional block Needle120008755HN2-402025-11-28
10193494001763PROBLOC* II Insulated Regional block Needle120008756HN2-802025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating Cable120008759EBL18100TGC2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008740EBL20100SG2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008741EBL20100SGC2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008742EBL20150SG2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008743EBL20150SGC2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008744EBL22050SG2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008745EBL22050SGC2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008746ELL18050SGC2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008747ELL18050TG2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008748ELL18050TGC2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008749ELL18100SGC2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008750ELL18100TG2025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153038AMT MiniONE Extension SetAPPLIED MEDICAL TECHNOLOGY, INC.PIF2026-03-23
50192253012505Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253012987Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253068786CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068793CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068816CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068823CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068830CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253011447CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011461CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011515CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011553CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011577CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011614CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
05060999351571EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351601EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351632EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351670EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
20813939024917VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024924VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024931VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024948VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024955VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024962VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
00850016172488KBMEDKB Medical (group), Inc.PIF2025-05-21
00850016172495KBMEDKB Medical (group), Inc.PIF2025-05-21
50192253007570ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007594ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007617ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007631ArgyleCardinal Health 200, LLCPIF2025-04-24