FDA.reportPublic FDA data

ENFit PU Feeding Tube

Primary DI
00350770000626
Brand
ENFit PU Feeding Tube
Company
Avanos Medical, Inc.
Model
FTM8.0P-NC
Catalog number
FTM8.0P-NC
Device description
ENFit PU Feeding Tube Orange 8Fr 60cm
Published
2021-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20350770000620PackageGS116In Commercial Distribution
00350770000626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035077000062020350770000620
00350770000626003507700006263507700006260350770000626

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.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
20350770002228NEOMED*Avanos Medical, Inc.BSS2021-04-23
20350770002266NEOMED*Avanos Medical, Inc.BSS2021-04-23
20350770002273NEOMED*Avanos Medical, Inc.BSS2021-04-23