FDA.report

Aero-Med

Primary DI
50810010890455
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
BRL140
Catalog number
BRL140
Device description
GenPath Bone Marrow Specimen Collection Kit
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

Related Records

Product Codes

CodeName
LWEBone marrow collection/transfusion kit

Product Code Classifications

CodeDeviceSpecialtyClass
LWEBone Marrow Collection/Transfusion KitUnknown2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50810010890455PackageGS1420In Commercial Distribution
10810010890457PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorConversion note
5081001089045514508100108904555Indicator 5 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1081001089045714108100108904571Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

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
true
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

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Primary DIBrandCompanyProduct codePublished
50198956138726CARDINAL HEALTHCardinal Health 200, LLCLWE2025-08-14
50810010894774Aero-MedAero-Med, Ltd.LWE2025-03-06
50197106464425CARDINAL HEALTHCardinal Health 200, LLCLWE2023-10-18
50197106385645CARDINAL HEALTHCardinal Health 200, LLCLWE2023-08-21
50197106202713CARDINAL HEALTHCardinal Health 200, LLCLWE2023-04-03
04086000100380Bone Marrow Collection StandFresenius Kabi AGLWE2022-08-17
M791MH21500BioAccess Marrow Collection SystemBIOACCESS INCLWE2022-08-03
50195594757326CARDINAL HEALTHCardinal Health 200, LLCLWE2022-07-21
50195594569998CARDINAL HEALTHCardinal Health 200, LLCLWE2022-03-18
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50888439403518CARDINAL HEALTHCardinal Health 200, LLCLWE2019-03-29
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50888439338889CARDINAL HEALTHCardinal Health 200, LLCLWE2019-02-19
50888439367315CARDINAL HEALTHCardinal Health 200, LLCLWE2019-02-04
50888439017999CARDINAL HEALTHCardinal Health 200, LLCLWE2018-06-13
50887488971061CARDINAL HEALTHCardinal Health 200, LLCLWE2018-04-26