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
10885380212017Aero-MedCA23425ACA23425A2026-06-04
10885380212024Aero-MedCA64200CA642002026-06-04
00810010894816Aero-MedAMM19875AMM198752025-06-26
10885380178481Aero-MedCA29575CA295752020-04-14
10810010891140CARDINAL HEALTHAMM542AMM5422019-04-26
00810010894991Aero-MedAMM10475AAMM10475A2026-04-07
00810010895004Aero-MedAMM12325AAMM12325A2026-04-07
10810010890990CARDINAL HEALTHFO2FO22019-04-26
10810010891027CARDINAL HEALTHAMM070AMM0702019-04-26
10810010891034CARDINAL HEALTHAMM080AMM0802019-04-26
10810010891041CARDINAL HEALTHAMM215AMM2152019-04-26
10810010891119CARDINAL HEALTHAMM521AMM5212019-04-26
10810010891164CARDINAL HEALTHAMM552AMM5522019-04-26
10810010891171CARDINAL HEALTHAMM579AMM5792019-04-26
10810010891225CARDINAL HEALTHAMM999AMM9992019-04-26
10810010891232CARDINAL HEALTHAMM1550AMM15502019-04-26
10810010891263CARDINAL HEALTHAMM1800AMM18002019-04-26
10810010891270CARDINAL HEALTHAMM1875AMM18752019-04-26
10810010891287CARDINAL HEALTHAMM1925AMM19252019-04-26
10810010891546CARDINAL HEALTHHHC100HHC1002019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50885380176973Aero-MedAero-Med, Ltd.OKY2020-01-21
10887488727585CARDINAL HEALTHCardinal Health 200, LLCOKY2017-05-30