FDA.reportPublic FDA data

AVANOS

Primary DI
00350770469201
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
46920
Catalog number
EES-150
Device description
Enteral Drainage Bags
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
10350770469208PackageGS110In Commercial Distribution
00350770469201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077046920810350770469208
00350770469201003507704692013507704692010350770469201

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
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15

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 GROUP LIMITEDFFD2022-10-19
05060460843697EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460843727EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460843758EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460845707EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060460848043EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060590889374EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060590889404EnteralGBUK GROUP LIMITEDFFD2022-10-19
05060590889435EnteralGBUK GROUP 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