Aero-Med

Primary DI
10885380176975
Brand
Aero-Med
Company
AERO-MED, LLC
Model
CA19925
Catalog number
CA19925
Device description
SurePath Cytology Convenience Kit, Health Partners Only
Published
2020-01-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKYCytology kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKYCytology KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380176973PackageGS18Not in Commercial Distribution
10885380176975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017697350885380176973
1088538017697510885380176975

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
194550042
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
10885380213908Aero-MedCA52100ACA52100A2026-09-25
10885380213922Aero-MedCA65350CA653502026-09-25
00810010894687Aero-MedAMM18150AMM181502026-09-24
10885380122057CARDINAL HEALTHCA1475CA14752019-04-12
10885380184376Aero-MedCA3100ACA3100A2021-02-24
10885380187902Aero-MedCA38275CA382752026-02-20
10885380189159Aero-MedCA36975CA369752026-02-20
10885380194733Aero-MedCA48325CA483252023-02-24
10885380195365Aero-MedCA49825CA498252023-04-20
10885380202605Aero-MedCA42225ACA42225A2024-05-10
10885380205217Aero-MedCA54650ACA54650A2024-08-28
10885380208515Aero-MedCA6000BCA6000B2025-06-19
10885380211195Aero-MedCA19925ACA19925A2026-02-13
10885380211218Aero-MedCA7225ACA7225A2026-03-20
10885380175237Aero-MedCA23450CA234502019-10-07
10885380199165Aero-MedCA52075CA520752024-01-31
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380211195Aero-MedAERO-MED, LLCOKY2026-02-13
10885380208515Aero-MedAERO-MED, LLCOKY2025-06-19
50885380176973Aero-MedAero-Med, Ltd.OKY2020-01-21
10887488727585CARDINAL HEALTHCardinal Health 200, LLCOKY2017-05-30