FDA.reportPublic FDA data

Aero-Med

Primary DI
50810010890509
Brand
Aero-Med
Company
AERO-MED, LLC
Model
BRL205
Catalog number
BRL205
Device description
ThinPrep Collection Tools; Combo
Published
2019-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OHLPap smear kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHLPap Smear KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010890509PackageGS1125In Commercial Distribution
10810010890501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5081001089050950810010890509
1081001089050110810010890501

GMDN Terms#

Term, Definition table
TermDefinition
Papanicolaou smear kitA packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10810010891294CARDINAL HEALTHAMM1950AMM19502019-04-26
10810010891300CARDINAL HEALTHAMM1951AMM19512019-04-26
10810010891317CARDINAL HEALTHAMM1952AMM19522019-04-26
10810010891324CARDINAL HEALTHAMM1953AMM19532019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594077877CARDINAL HEALTHCardinal Health 200, LLCOHL2021-06-07
50195594077875CARDINAL HEALTHCardinal Health 200, LLCOHL2021-06-07
10810010890471Aero-MedAERO-MED, LLCOHL2019-01-16
10810010890501Aero-MedAERO-MED, LLCOHL2019-01-16
50810010890479Aero-MedAERO-MED, LLCOHL2019-01-16
10888439311617CARDINAL HEALTHCardinal Health 200, LLCOHL2019-01-14
50888439311615CARDINAL HEALTHCardinal Health 200, LLCOHL2019-01-14
10887488944845CARDINAL HEALTHCardinal Health 200, LLCOHL2018-04-30
50887488944843CARDINAL HEALTHCardinal Health 200, LLCOHL2018-04-30
10809160158739Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
10809160159125Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
20809160159122Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
00187207000085Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000092Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000108Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000122Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000139Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000146Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000153Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000160Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000177Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000184Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000191Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000207Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000078Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000089Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000096Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000102Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000126Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000133Andwin ScientificAndwin ScientificOHL2017-08-02