FDA.reportPublic FDA data

Xpeedy

Primary DI
10860012318213
Brand
Xpeedy
Company
Cura Diagnostics Inc.
Model
Xpeedy Urine Collection Tube - Yellow Cup
Device description
Xpeedy Vaccum Urine Collection Tube 16 mm x 100 mm, Yellow Cap
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10860012318213PackageGS112In Commercial Distribution
00860012318216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001231821310860012318213
00860012318216008600123182168600123182160860012318216

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119132639
Device count
1
DM exempt
false
Premarket exempt
true
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
00860012318209XpeedyVaccum Urine Collection Tube White Cap2025-01-31
00860012318216XpeedyXpeedy Urine Collection Tube - Yellow Cup2025-01-31
00860012318223XpeedyUrine Collection Cup2025-01-31
10860012318206XpeedyVaccum Urine Collection Tube White Cap2025-01-31
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
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00810185250035TherapakTherapak LLCMPQ2025-08-11
00810185250073TherapakTherapak LLCMPQ2025-08-11
00810185250097TherapakTherapak LLCMPQ2025-08-11
00810185250134TherapakTherapak LLCMPQ2025-08-11
00810185250158TherapakTherapak LLCMPQ2025-08-11
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00810185250301TherapakTherapak LLCMPQ2025-08-04
00810185250325TherapakTherapak LLCMPQ2025-08-04
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00810185250332TherapakTherapak LLCMPQ2025-08-04
00810185250592TherapakTherapak LLCMPQ2025-08-04