Ameritus

Primary DI
10817522011554
Brand
Ameritus
Company
KENTEC MEDICAL, INC.
Model
AEG-40P-40
Catalog number
AEG-40P-40
Device description
4fr 40cm single port feeding tube
Published
2018-06-04
Public version status
New
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
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
20817522011551PackageGS110In Commercial Distribution
30817522011558PackageGS1200In Commercial Distribution
10817522011554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081752201155120817522011551
3081752201155830817522011558
1081752201155410817522011554

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08015262037390VYGONVygon CorporationFPD2024-05-08
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
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
10680651466454HalyardAvanos Medical, Inc.FPD2018-01-19