Home GUDID 10194717120087 Regard™
Primary DI 10194717120087
Brand Regard™
Company ROI CPS, LLC
Model AN01272A
Device description BLOOD CULTURE COLLECTION KIT
Published 2024-10-02
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 20194717120084 Package GS1 40 Not in Commercial Distribution 10194717120087 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717120084 20194717120084 10194717120087 10194717120087
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A 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 117174678 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true 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 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 10195327374990 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OIB 2023-04-23