FDA.reportPublic FDA data

Stratis®

Primary DI
00856457003367
Brand
Stratis®
Company
PHARMAJET, INC.
Model
C501-43
Catalog number
C501-43
Device description
Stratis® Filling Adapter
Published
2016-09-19
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

Product Codes#

Code, Name table
CodeName
KZEInjector, Fluid, Non-Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZEInjector, Fluid, Non-Electrically PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111517000PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.2011-07-27KZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856457003367PackageGS1100In Commercial Distribution
10856457003364PackageGS110In Commercial Distribution
00856457003329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856457003367008564570033678564570033670856457003367
1085645700336410856457003364
00856457003329008564570033298564570033290856457003329

GMDN Terms#

Term, Definition table
TermDefinition
Vial transfer spikeA sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial?s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial?s contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
609816892
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856457003329Stratis®C501-43C501-432016-09-19
00856457003336Stratis®C501-46C501-462016-09-19
00856457003206Stratis®C501-10C501-102016-09-19
00856457003213Stratis®C501-20C501-202016-09-19
00856457003305Stratis®C501-32C501-322016-09-19
00856457003312Stratis®C501-34C501-342016-09-19
00856457003374Stratis®C501-46C501-462016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284222250Robbins Dermo-jetRobbins Instruments Inc.KZE2025-08-22
07290016746754Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746761Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746716ConsoleVIORA LTDKZE2025-05-22
07290016746723ApplicatorVIORA LTDKZE2025-05-22
07290016746730TrolleyVIORA LTDKZE2025-05-22
07290016746747Disposable Delivery NozzleVIORA LTDKZE2025-05-22
B07281641001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
B07281642001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
07290017151007AirGent-2.0PERFACTION TECHNOLOGIES LTDKZE2018-12-18
07640180261018ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
07640180261001ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
00856457003329Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003336Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003206Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003213Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003305Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003312Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003374Stratis®PHARMAJET, INC.KZE2016-09-19