FDA.reportPublic FDA data

AVANOS

Primary DI
00350770469218
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
46921
Catalog number
EDS-250
Device description
Enteral Drainage System
Published
2020-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFDEVACUATOR, BLADDER, MANUALLY OPERATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFDEvacuator, Bladder, Manually OperatedGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770469215PackageGS130In Commercial Distribution
00350770469218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077046921510350770469215
00350770469218003507704692183507704692180350770469218

GMDN Terms#

Term, Definition table
TermDefinition
Gastric drainage/decompression bagA plastic sac intended to be used to collect stomach contents during gastric drainage/decompression, via an enteral tube (not included), to drain/empty stomach contents (e.g., prior to surgery, as therapy for obstructed bowel). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
04059453040756Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFFD2025-08-25
05906168942228Dual Action Pump HandWISMED PL SP Z O OFFD2025-03-17
05906168942211Dual Action Pump FootWISMED PL SP Z O OFFD2025-03-17
59061689422282Dual Action Pump HandWISMED PL SP Z O OFFD2025-03-17
00810143891249Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
00810143891256Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
06936881168789Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
06936881168796Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
06936881168802Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168783Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168790Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168806Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
00190776299668MillenniumAvalign Technologies, Inc.FFD2023-06-23
05060460843666EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843697EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843727EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843758EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460845707EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460848043EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889374EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889404EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889435EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843680EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843710EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843741EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843765EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460845714EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460848050EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889398EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889428EnteralGBUK ENTERAL LIMITEDFFD2022-10-19