FDA.reportPublic FDA data

Ameritus ENFit

Primary DI
10817522012810
Brand
Ameritus ENFit
Company
KENTEC MEDICAL, INC.
Model
ENF-EXT-Y060
Catalog number
ENF-EXT-Y060
Device description
"60"" enteral extension set w/ dual ENFit connectors"
Published
2016-08-03
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
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120272000AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETKentec Medical, Inc.2012-02-17KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817522012817PackageGS1100In Commercial Distribution
30817522012814PackageGS1800In Commercial Distribution
10817522012810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081752201281720817522012817
3081752201281430817522012814
1081752201281010817522012810

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
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

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Primary DI, Brand, Company table
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00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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