FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10810010891430
Brand
CARDINAL HEALTH
Company
AERO-MED, LLC
Model
HH8000
Catalog number
HH8000
Device description
Lab In A Pouch
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810010891430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081001089143010810010891430

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K2EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17
10197344039708MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-16
10197344132911MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10197344132928MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10850074089060SurgycoSurgyco LLCJKA2025-12-23
10850074089077SurgycoSurgyco LLCJKA2025-12-23
10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
10850074089107SurgycoSurgyco LLCJKA2025-12-23
10850074089114SurgycoSurgyco LLCJKA2025-12-23
10612479275635McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275666McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275697McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275727McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275758McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275789McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275819McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275840McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10193489189643MEDLINEMEDLINE INDUSTRIES, INC.JKA2025-07-10