FDA.reportPublic FDA data

Aero-Med

Primary DI
50885380184367
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA34950
Catalog number
CA34950
Device description
Blood Culture Collection Kit, 23G SteriPath Gen2, Baylor Scott & White Only
Published
2022-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380184367PackageGS150In Commercial Distribution
10885380184369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538018436750885380184367
1088538018436910885380184369

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10192253061031Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061093Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061109Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061475Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061482Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061505Aero-MedAERO-MED, LLCOIB2026-02-20
10194717120087Regard™ROI CPS, LLCOIB2024-10-02
10194717119739Regard™ROI CPS, LLCOIB2024-07-19
10194717119449Regard™ROI CPS, LLCOIB2024-05-21
10195327338220Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-12-21
10192253064650Aero-MedAERO-MED, LLCOIB2023-11-15
10194717117865Regard™ROI CPS, LLCOIB2023-11-09
10192253064001Aero-MedAERO-MED, LLCOIB2023-10-12
10192253064018Aero-MedAERO-MED, LLCOIB2023-10-12
10194717117834Regard™ROI CPS, LLCOIB2023-09-29
10192253064346Aero-MedAERO-MED, LLCOIB2023-09-25
10192253064339CARDINAL HEALTHAERO-MED, LLCOIB2023-08-24
10195327228576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327256647Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327281359Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327344672Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327345808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327347550Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327356163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327365479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327264833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-08
10195327265120Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-08
10195327282462Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-04-23
10195327353490Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-04-23