FDA.reportPublic FDA data

Ameritus

Primary DI
10817522010144
Brand
Ameritus
Company
KENTEC MEDICAL, INC.
Model
120P
Catalog number
120P
Device description
120P medium size probe cover
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817522010141PackageGS1120In Commercial Distribution
30817522010148PackageGS14880In Commercial Distribution
10817522010144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081752201014120817522010141
3081752201014830817522010148
1081752201014410817522010144

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor/probe cover, non-sterileA non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
066175613
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07