FDA.reportPublic FDA data

Aero-Med

Primary DI
10192253065442
Brand
Aero-Med
Company
AERO-MED, LLC
Model
CA55050
Catalog number
CA55050
Device description
Kit Renal Biopsy for The Ohio State University Only
Published
2024-03-11
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
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253065440PackageGS120Not in Commercial Distribution
10192253065442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306544050192253065440
1019225306544210192253065442

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.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213908Aero-MedCA52100ACA52100A2026-09-25
10885380213922Aero-MedCA65350CA653502026-09-25
00810010894687Aero-MedAMM18150AMM181502026-09-24
10885380122057CARDINAL HEALTHCA1475CA14752019-04-12
10885380184376Aero-MedCA3100ACA3100A2021-02-24
10885380187902Aero-MedCA38275CA382752026-02-20
10885380189159Aero-MedCA36975CA369752026-02-20
10885380194733Aero-MedCA48325CA483252023-02-24
10885380195365Aero-MedCA49825CA498252023-04-20
10885380202605Aero-MedCA42225ACA42225A2024-05-10
10885380205217Aero-MedCA54650ACA54650A2024-08-28
10885380208515Aero-MedCA6000BCA6000B2025-06-19
10885380211195Aero-MedCA19925ACA19925A2026-02-13
10885380211218Aero-MedCA7225ACA7225A2026-03-20
10885380175237Aero-MedCA23450CA234502019-10-07
10885380199165Aero-MedCA52075CA520752024-01-31
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
00749756394666DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756397193DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401715DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15