FDA.reportPublic FDA data

NEOMED*

Primary DI
20350770002174
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
FTS4.0P-EO
Catalog number
FTS4.0P-EO
Device description
PU Feeding Tube Orange 4Fr 40cm
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
FPDTUBE, FEEDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSSTube, NasogastricGastroenterology, Urology2
FPDTube, FeedingGastroenterology, 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
10350770002177PackageGS110In Commercial Distribution
20350770002174PackageGS116In Commercial Distribution
00350770002170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000217710350770002177
2035077000217420350770002174
00350770002170003507700021703507700021700350770002170

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
false
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
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31
00812120005120Game Ready* Ankle Wrap, Extra Large120008550590340-042026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, Right120008551590422-042026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, Left120008552590424-042026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, Right120008553590432-042026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, Left120008554590434-042026-07-31
00812120005175Game Ready* Back Wrap120008555590500-042026-07-31
00812120005182Game Ready* C-T Spine Wrap, Large120008556590502-042026-07-31
00812120005199Game Ready* Hip/Groin Wrap, Right120008557590602-042026-07-31
00812120005205Game Ready* Hip/Groin Wrap, Left120008558590604-042026-07-31
00812120005212Game Ready* Hand/Wrist Wrap120008559590811-042026-07-31
00812120005229Game Ready* Flexed Elbow Wrap120008560590903-042026-07-31
00812120005236Game Ready* Half Leg Boot Wrap120008561590906-042026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, Large120008562590922-042026-07-31
00812120005250Game Ready* Straight Knee Sleeve120009290510100-042026-07-31
00812120005267Game Ready* Articulated Knee Sleeve120009291510160-042026-07-31
00812120005274Game Ready* Straight Elbow Sleeve120009292510200-042026-07-31
00812120005281Game Ready* Ankle Sleeve, Large120009293510330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08015262039943VYGONVygon CorporationFPD2024-05-08
08015262022266VYGONVygon CorporationFPD2024-03-22
10680651456813HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456844HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456868HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456875HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456899HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456912HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457025HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457100HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457179HalyardAvanos Medical, Inc.FPD2018-10-04
10817522010151Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522010182Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522010205Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522011554Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011561Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011684Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011691Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10680651457513HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457544HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457568HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457582HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457605HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457629HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457650HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457681HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457704HalyardAvanos Medical, Inc.FPD2018-01-19
10680651466430HalyardAvanos Medical, Inc.FPD2018-01-19
10680651466447HalyardAvanos Medical, Inc.FPD2018-01-19