FDA.reportPublic FDA data

NEOMED*

Primary DI
20350770002228
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
FTM6.5P-EO
Catalog number
FTM6.5P-EO
Device description
PU Feeding Tube Orange 6.5Fr 60cm
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSSTUBE, NASOGASTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSSTube, NasogastricGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082238000NEOMED POLYURETHANE FEEDING TUBENeomed, Inc.2008-10-01FPD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770002221PackageGS110In Commercial Distribution
20350770002228PackageGS116In Commercial Distribution
00350770002224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000222110350770002221
2035077000222820350770002228
00350770002224003507700022243507700022240350770002224

GMDN Terms#

Term, Definition table
TermDefinition
Nasoenteral tubeA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. 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
false
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
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00350770002293PU Feeding TubeAvanos Medical, Inc.BSS2021-05-05
20350770002297NEOMED*Avanos Medical, Inc.BSS2021-05-05
00350770002170PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002200PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002224PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002262PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002279PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002286PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002309PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002316PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002330PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002347PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002354PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002361PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002385PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002392PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002408PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002187PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002194PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002217PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002231PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002248PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002255PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002323PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
00350770002378PU Feeding TubeAvanos Medical, Inc.BSS2021-04-23
20350770002174NEOMED*Avanos Medical, Inc.BSS2021-04-23
20350770002204NEOMED*Avanos Medical, Inc.BSS2021-04-23
20350770002266NEOMED*Avanos Medical, Inc.BSS2021-04-23
20350770002273NEOMED*Avanos Medical, Inc.BSS2021-04-23
20350770002280NEOMED*Avanos Medical, Inc.BSS2021-04-23