Ameritus ENFit

Primary DI
30817522013101
Brand
Ameritus ENFit
Company
KENTEC MEDICAL, INC.
Model
ENF-Y60P-90U
Catalog number
ENF-Y60P-90U
Device description
6fr 90cm dual port feeding tube with ENFit connector
Published
2018-06-20
Public version status
Update
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
FPDTube, Feeding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100526000AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEKentec Medical, Inc.2010-04-22FPD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817522013104PackageGS110In Commercial Distribution
30817522013101PackageGS1200In Commercial Distribution
10817522013107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081752201310420817522013104
3081752201310130817522013101
1081752201310710817522013107

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric/orogastric tubeA sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
949-863-0810kjrooks@kentecmedical.com

Regulatory Flags#

DUNS number
066175613
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817522010250Kentec ArmBoard403AB403AB2021-12-16
10817522010267Kentec ArmBoard403ABV403ABV2021-12-16
10817522010298Kentec ArmBoard404ABV404ABV2021-12-16
10817522010311Kentec ArmBoard405AB405AB2021-12-16
10817522010328Kentec ArmBoard405ABV405ABV2021-12-16
10817522010281Kentec ArmBoard404AB404AB2021-12-16
10817522010694Ameritus TransducerATG200-TATG200-T2016-09-21
00817522013377SwabezeKMI-40KMI-402024-06-28
20817522013371SwabezeKMI-40KMI-402024-06-28
00817522013353SwabezeKMI-65KMI-652024-06-27
00817522013360SwabezeKMI-74KMI-742024-06-27
00817522013384SwabezeKMI-111KMI-1112024-06-27
20817522013357SwabezeKMI-65KMI-652024-06-27
20817522013364SwabezeKMI-74KMI-742024-06-27
20817522013388SwabezeKMI-111KMI-1112024-06-27
10817522013343SwabezeKMI-LAKMI-LA2024-06-20
20817522013340SwabezeKMI-LAKMI-LA2024-06-20
10817522010359AmeritusAMG-503-LGAMG-503-LG2016-08-01
10817522010366AmeritusAMG-503-SMAMG-503-SM2016-08-01
10817522013336Kentec electrodeAMG-503-PEDAMG-503-PED2024-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08015262037390VYGONVygon CorporationFPD2024-05-08
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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