FDA.reportPublic FDA data

Aero-Med

Primary DI
10810010890457
Brand
Aero-Med
Company
AERO-MED, LLC
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
Single use
true

Product Codes#

Code, Name table
CodeName
LWEBone marrow collection/transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWEBone Marrow Collection/Transfusion KitUnknown2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010890455PackageGS1420In Commercial Distribution
10810010890457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5081001089045550810010890455
1081001089045710810010890457

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
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
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26
10192253062618Aero-MedCA37875CA378752022-08-26
10192253063561Aero-MedCA44175CA441752023-02-14
10192253063578Aero-MedCA44200CA442002023-02-14
10192253063950Aero-MedCA47175CA471752023-03-15
10192253064001Aero-MedCA48700CA487002023-10-12
10885380193255Aero-MedCA2250CCA2250C2022-07-20
10885380193262Aero-MedCA2275BCA2275B2022-07-20
10885380193538Aero-MedCA44225CA442252022-08-10
10885380193637Aero-MedCA44875CA448752022-08-24
10885380193675Aero-MedCA43775CA437752022-09-09
10885380193828Aero-MedCA44550ACA44550A2022-10-04
10885380193835Aero-MedCA44575ACA44575A2022-10-04
10885380193859Aero-MedCA45525CA455252022-10-14
10885380193965Aero-MedCA46725CA467252022-11-21
10885380194108Aero-MedCA46250CA462502022-12-15
10885380194153Aero-MedCA44900CA449002023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397033CARDINAL HEALTHCardinal Health 200, LLCLWE2026-05-19
10198956138728CARDINAL HEALTHCardinal Health 200, LLCLWE2025-08-14
50198956138726CARDINAL HEALTHCardinal Health 200, LLCLWE2025-08-14
00810010894779Aero-MedAERO-MED, LLCLWE2025-03-06
50810010894774Aero-MedAero-Med, Ltd.LWE2025-03-06
10197106464427CARDINAL HEALTHCardinal Health 200, LLCLWE2023-10-18
50197106464425CARDINAL HEALTHCardinal Health 200, LLCLWE2023-10-18
10197106385647CARDINAL HEALTHCardinal Health 200, LLCLWE2023-08-21
50197106385645CARDINAL HEALTHCardinal Health 200, LLCLWE2023-08-21
10197106202715CARDINAL HEALTHCardinal Health 200, LLCLWE2023-04-03
50197106202713CARDINAL HEALTHCardinal Health 200, LLCLWE2023-04-03
04086000100380Bone Marrow Collection StandFresenius Kabi AGLWE2022-08-17
M791MH21500BioAccess Marrow Collection SystemBIOACCESS INCLWE2022-08-03
10195594757328CARDINAL HEALTHCardinal Health 200, LLCLWE2022-07-21
50195594757326CARDINAL HEALTHCardinal Health 200, LLCLWE2022-07-21
10195594569990CARDINAL HEALTHCardinal Health 200, LLCLWE2022-03-18
50195594569998CARDINAL HEALTHCardinal Health 200, LLCLWE2022-03-18
00880304640962Bilateral BMA KitBiomet Biologics, LLCLWE2021-10-30
10195594365998CARDINAL HEALTHCardinal Health 200, LLCLWE2021-10-07
50195594365996CARDINAL HEALTHCardinal Health 200, LLCLWE2021-10-07
10888439974607CARDINAL HEALTHCardinal Health 200, LLCLWE2021-04-22
50888439974605CARDINAL HEALTHCardinal Health 200, LLCLWE2021-04-22
10888439940060CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-15
50888439940068CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-15
10888439974737CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-04
50888439974735CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-04
10888439969085CARDINAL HEALTHCardinal Health 200, LLCLWE2020-12-21
50888439969083CARDINAL HEALTHCardinal Health 200, LLCLWE2020-12-21
10888439897265CARDINAL HEALTHCardinal Health 200, LLCLWE2020-10-13
50888439897263CARDINAL HEALTHCardinal Health 200, LLCLWE2020-10-13