Home GUDID 50885380174191 Aero-Med
Primary DI 50885380174191
Brand Aero-Med
Company Aero-Med, Ltd.
Model CA26025
Catalog number CA26025
Device description Prostate Biopsy Kit, 12 Place, Trumbull Memorial Hospital Only
Published 2019-07-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name OIB Blood and urine collection kit (excludes HIV testing)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50885380174191 Package GS1 10 In Commercial Distribution 10885380174193 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50885380174191 50885380174191 10885380174193 10885380174193
GMDN Terms# Term, Definition table Term Definition Specimen mailer kit A collection of items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10192253071504 Aero-Med AERO-MED, LLC OIB 2026-04-16 10192253061031 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061093 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061109 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061475 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061482 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061505 Aero-Med AERO-MED, LLC OIB 2026-02-20 10194717120087 Regard™ ROI CPS, LLC OIB 2024-10-02 10194717119739 Regard™ ROI CPS, LLC OIB 2024-07-19 10194717119449 Regard™ ROI CPS, LLC OIB 2024-05-21 10195327338220 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-12-21 10192253064650 Aero-Med AERO-MED, LLC OIB 2023-11-15 10194717117865 Regard™ ROI CPS, LLC OIB 2023-11-09 10192253064001 Aero-Med AERO-MED, LLC OIB 2023-10-12 10192253064018 Aero-Med AERO-MED, LLC OIB 2023-10-12 10194717117834 Regard™ ROI CPS, LLC OIB 2023-09-29 10192253064346 Aero-Med AERO-MED, LLC OIB 2023-09-25 10192253064339 CARDINAL HEALTH AERO-MED, LLC OIB 2023-08-24 10195327228576 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327256647 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327281359 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327344672 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327345808 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327347550 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327356163 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327365479 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-13 10195327264833 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-08 10195327265120 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-06-08 10195327282462 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-04-23 10195327353490 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-04-23