FDA.reportPublic FDA data

AVANOS*

Primary DI
00193494135263
Brand
AVANOS*
Company
Avanos Medical, Inc.
Model
5001087
Catalog number
5001087
Device description
E-Clips
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEBPump, infusion, elastomeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984502000NERVE BLOCK INFUSION KITI-Flow Corp.1999-03-04MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193494135263PrimaryGS10
10193494135260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193494135263001934941352631934941352630193494135263
1019349413526010193494135260

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
100
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299151073SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-10-06
18859299150984SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299151080SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299151097SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299151103SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299175079SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
18859299175178SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
18859299175185SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
18859299175192SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
10612479280189McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280202McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280226McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280240McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280264McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280288McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280301McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280325McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280349McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280363McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280387McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280400McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280424McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280448McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280462McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479271323McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271347McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271361McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271385McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271408McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271422McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20