FDA.report

Aero-Med

Primary DI
50885380181007
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA32700
Catalog number
CA32700
Device description
PGX Specimen Transport Kit, Sanford Medical Center Sioux Falls SD Only
Published
2020-08-06
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

Related Records

Product Codes

CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380181007PackageGS14In Commercial Distribution
10885380181009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538018100750885380181007
1088538018100910885380181009

GMDN Terms

TermDefinition
General specimen receptacle transport containerA non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

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 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 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