FDA.reportPublic FDA data

AVANOS

Primary DI
10350770469215
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
46921
Catalog number
EDS-250
Device description
ENFIT ENTERAL DRAINAIGE BAG
Published
2020-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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.

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
true
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
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