Home GUDID 10194717113089 Regard™
Primary DI 10194717113089
Brand Regard™
Company ROI CPS, LLC
Model LD01182
Device description NICU DAY KIT
Published 2021-09-29
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KME Bedding, Disposable, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KME Bedding, Disposable, Medical General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717113086 Package GS1 20 Not in Commercial Distribution 10194717113089 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717113086 20194717113086 10194717113089 10194717113089
GMDN Terms# Term, Definition table Term Definition Birthing/delivery kit A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. 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 00840117349544 Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm) Dynarex Corporation KME 2026-06-08 00840117349568 Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm) Dynarex Corporation KME 2026-06-08 16931918119823 Alleset GRI Medical & Electronic Technology Co., Ltd. KME 2026-06-04 00199536911109 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 00199536911116 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 00199536911123 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 00199536911130 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 00199536911147 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 00199536911154 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 00199536911161 Blueline Transparent Supply Solutions Ltd. KME 2026-05-15 10304040196660 Henry Schein HENRY SCHEIN, INC. KME 2026-04-17 10304040196677 Henry Schein HENRY SCHEIN, INC. KME 2026-04-17 10304040196684 Henry Schein HENRY SCHEIN, INC. KME 2026-04-17 10304040196691 Henry Schein HENRY SCHEIN, INC. KME 2026-04-17 10304040196707 Henry Schein HENRY SCHEIN, INC. KME 2026-04-17 10304040196714 Henry Schein HENRY SCHEIN, INC. KME 2026-04-17 16931918105475 Alleset GRI Medical & Electronic Technology Co., Ltd. KME 2026-03-18 07613327632842 Sage Multi-Position MATS 2.0 SAGE PRODUCTS, LLC KME 2025-11-19 07613327672718 Sage Multi-Position MATS 2.0 SAGE PRODUCTS, LLC KME 2025-11-19 M68959120030 Hypothermia Management Set Safeguard US Operating, LLC KME 2025-10-24 10304040193157 Henry Schein HENRY SCHEIN, INC. KME 2025-09-03 16931918129815 HALYARD GRI Medical & Electronic Technology Co., Ltd. KME 2025-06-20 10889483602911 AirLife™ AirLife Finland Oy KME 2025-04-17 10889483602928 AirLife™ AirLife Finland Oy KME 2025-04-17 10889483602935 AirLife™ AirLife Finland Oy KME 2025-04-17 10889483602942 AirLife™ AirLife Finland Oy KME 2025-04-17 10889483603031 AirLife™ AirLife Finland Oy KME 2025-04-17 10889483603048 AirLife™ AirLife Finland Oy KME 2025-04-17 10603354120669 ComfortTop EHOB INC KME 2025-01-22 M68959320040 HAWK Advanced Hypothermia Management Set Safeguard US Operating, LLC KME 2024-10-08