FDA.reportPublic FDA data

AVANOS

Primary DI
00350770000022
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
00002
Catalog number
SL-0016
Device description
CORFLO* PEG Silicone Fixation Device
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLIGastrointestional Tube Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLIGastrointestional Tube HolderGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00350770000022PrimaryGS10
10350770000067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770000022003507700000223507700000220350770000022
1035077000006710350770000067

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding noninvasive-component setA collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1095816020630-202026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1095818020630-242026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095822020640-142026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095823020640-202026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095824020640-242026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095828020644-142026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095829020644-202026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095830020644-242026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095832020645-202026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095833020645-242026-10-20
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14

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Primary DI, Brand, Company table
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40612479262162McKessonMCKESSON MEDICAL-SURGICAL INC.PLI2026-02-23
G736110210110Button HuggieEZALIFE LLCPLI2025-08-14
10618125192189Grip-LokTIDI PRODUCTS, LLCPLI2024-12-02
10618125192196Grip-LokTIDI PRODUCTS, LLCPLI2024-12-02
10618125192202Grip-LokTIDI PRODUCTS, LLCPLI2024-12-02
20812594013236NeoSnug MicroNeotech Products LLCPLI2024-10-14
20812594013243NeoSnug Oral - SmallNeotech Products LLCPLI2024-10-14
10812594013239NeoSnug MicroNeotech Products LLCPLI2024-10-14
10812594013246NeoSnug Oral - SmallNeotech Products LLCPLI2024-10-14
20812594012925NeoSnug SmallNeotech Products LLCPLI2023-09-08
10812594012928NeoSnugNeotech Products LLCPLI2023-09-08
00618125134991Grip-LokTIDI PRODUCTS, LLCPLI2022-10-13
10618125134998Grip-LokTIDI PRODUCTS, LLCPLI2022-10-13
00618125134601Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
00618125134618Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
00618125134656Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
00618125134670Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
00618125134755Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
10618125134608Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
10618125134615Grip-LokTIDI PRODUCTS, LLCPLI2022-10-12
00350770000015AVANOSAvanos Medical, Inc.PLI2020-05-08
00350770000039AVANOSAvanos Medical, Inc.PLI2020-05-08
00350770000046AVANOSAvanos Medical, Inc.PLI2020-05-08
00350770000053AVANOSAvanos Medical, Inc.PLI2020-05-08
00350770000060AVANOSAvanos Medical, Inc.PLI2020-05-08