Home GUDID 20194717117831 Regard™
Primary DI 20194717117831
Brand Regard™
Company ROI CPS, LLC
Model AN01239
Device description BLOOD CULTURE COLLECTION KIT-ED
Published 2023-09-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OFM Phlebotomy Blood Collection Kit OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OFM Phlebotomy Blood Collection Kit Cardiovascular 2 OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717117831 Package GS1 40 In Commercial Distribution 10194717117834 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717117831 20194717117831 10194717117834 10194717117834
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 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 10885380214516 Aero-Med AERO-MED, LLC OIB 2026-10-19 10885380213960 Aero-Med AERO-MED, LLC OIB 2026-10-07 10885380213953 Aero-Med AERO-MED, LLC OIB 2026-10-06 10885380193002 Aero-Med AERO-MED, LLC OIB 2026-09-29 10192253057591 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253063226 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253063332 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253066760 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253067644 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380185045 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380185052 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380187889 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380190261 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380190988 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380195822 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380196812 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380196829 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200601 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200823 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200830 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200892 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380202841 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380203169 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206559 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206566 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206573 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206580 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206597 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380207662 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380208836 Aero-Med AERO-MED, LLC OIB 2026-09-28