FDA.reportPublic FDA data

Xpeedy

Primary DI
00860012318223
Brand
Xpeedy
Company
Cura Diagnostics Inc.
Model
Urine Collection Cup
Device description
Xpeedy Urine Collection Cup - 90mL, with Vaccum Lid, Sterile
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The CounterPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860012318220PackageGS1250In Commercial Distribution
00860012318223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001231822010860012318220
00860012318223008600123182238600123182230860012318223

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated urine specimen container IVD, no additiveA covered receptacle containing a pre-measured amount of vacuum with no additives, intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.

Regulatory Flags#

DUNS number
119132639
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
00860012318209XpeedyVaccum Urine Collection Tube White Cap2025-01-31
00860012318216XpeedyXpeedy Urine Collection Tube - Yellow Cup2025-01-31
10860012318206XpeedyVaccum Urine Collection Tube White Cap2025-01-31
10860012318213XpeedyXpeedy Urine Collection Tube - Yellow Cup2025-01-31
10860012318220XpeedyUrine Collection Cup2025-01-31
00860012318230XpeedyDOA202024-07-19
06975141982086CURAXpeedy DOA202024-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810185250028TherapakTherapak LLCMPQ2025-08-11
00810185250066TherapakTherapak LLCMPQ2025-08-11
00810185250080TherapakTherapak LLCMPQ2025-08-11
00810185250127TherapakTherapak LLCMPQ2025-08-11
00810185250141TherapakTherapak LLCMPQ2025-08-11
00810185250226TherapakTherapak LLCMPQ2025-08-11
00810185250240TherapakTherapak LLCMPQ2025-08-11
00810185250660TherapakTherapak LLCMPQ2025-08-11
00810185250035TherapakTherapak LLCMPQ2025-08-11
00810185250073TherapakTherapak LLCMPQ2025-08-11
00810185250097TherapakTherapak LLCMPQ2025-08-11
00810185250134TherapakTherapak LLCMPQ2025-08-11
00810185250158TherapakTherapak LLCMPQ2025-08-11
00810185250233TherapakTherapak LLCMPQ2025-08-11
00810185250257TherapakTherapak LLCMPQ2025-08-11
00810185250677TherapakTherapak LLCMPQ2025-08-11
00810185250103TherapakTherapak LLCMPQ2025-08-04
00810185250165TherapakTherapak LLCMPQ2025-08-04
00810185250264TherapakTherapak LLCMPQ2025-08-04
00810185250288TherapakTherapak LLCMPQ2025-08-04
00810185250301TherapakTherapak LLCMPQ2025-08-04
00810185250325TherapakTherapak LLCMPQ2025-08-04
00810185250585TherapakTherapak LLCMPQ2025-08-04
00810185250110TherapakTherapak LLCMPQ2025-08-04
00810185250172TherapakTherapak LLCMPQ2025-08-04
00810185250271TherapakTherapak LLCMPQ2025-08-04
00810185250295TherapakTherapak LLCMPQ2025-08-04
00810185250318TherapakTherapak LLCMPQ2025-08-04
00810185250332TherapakTherapak LLCMPQ2025-08-04
00810185250592TherapakTherapak LLCMPQ2025-08-04