FDA.reportPublic FDA data

AMSure® Specimen Cup

Primary DI
10704411008415
Brand
AMSure® Specimen Cup
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
AS345
Device description
AMSure® Specimen CupCONTENTS: 4 oz Graduated Cup with Screw Cap
Published
2018-06-05
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

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411008416PackageGS1100In Commercial Distribution
10704411008415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100841640704411008416
1070441100841510704411008415

GMDN Terms#

Term, Definition table
TermDefinition
Sputum specimen container IVDA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a sputum specimen for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825673239
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10704411017080AMSure ® Hydrophilic Latex Foley Catheters1AS41012HC2026-05-15
10704411017097AMSure ® Hydrophilic Latex Foley Catheters1AS41014HC2026-05-15
10704411017103AMSure ® Hydrophilic Latex Foley Catheters1AS41016HC2026-05-15
10704411017110AMSure ® Hydrophilic Latex Foley Catheters1AS41018HC2026-05-15
10704411017127AMSure ® Hydrophilic Latex Foley Catheters1AS41020HC2026-05-15
10704411017134AMSure ® Hydrophilic Latex Foley Catheters1AS41022HC2026-05-15
10704411017141AMSure ® Hydrophilic Latex Foley Catheters1AS41024HC2026-05-15
10704411017158AMSure ® Hydrophilic Latex Foley Catheters1AS42016HC2026-05-15
10704411017165AMSure ® Hydrophilic Latex Foley Catheters1AS42018HC2026-05-15
10704411017172AMSure ® Hydrophilic Latex Foley Catheters1AS42020HC2026-05-15
10704411017189AMSure ® Hydrophilic Latex Foley Catheters1AS42022HC2026-05-15
10704411017196AMSure ® Hydrophilic Latex Foley Catheters1AS42024HC2026-05-15
10704411021544AMSure® Cystoscopy/Bladder Irrigation Set1ABL4002026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation Set1ABL4042026-04-10
10704411018834AMSure ® SUTURE REMOVAL KIT1SRT0012026-04-03
10704411018841AMSure ® Suture Removal Kit1SRT0022026-04-03
10704411018858AMSure ® Suture Removal Kit1SRT001Z2026-04-03
40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
40704411007471AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10102026-04-03
40704411007488AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10032026-04-03

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