Aero-Med

Primary DI
50885380177031
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA17350
Catalog number
CA17350
Device description
Urine Collection Kit, Virginia Commonwealth University Only
Published
2020-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380177031PackageGS1100In Commercial Distribution
10885380177033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017703150885380177031
1088538017703310885380177033

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253061039Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061091Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061107Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061473Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061480Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061503Aero-MedAERO-MED, LLCOIB2026-02-20
50885380176119Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185036Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185067Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185166Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185180Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186521Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186569Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186590Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186644Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186668Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186675Aero-MedAERO-MED, LLCOIB2026-02-20
50885380187900Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188525Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188662Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188754Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188761Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188792Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189157Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189393Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189409Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189447Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189454Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189898Aero-MedAERO-MED, LLCOIB2026-02-20
50885380190979Aero-MedAERO-MED, LLCOIB2026-02-20