Home GUDID 20326053123539 Regard™
Primary DI 20326053123539
Brand Regard™
Company Resource Optimization & Innovation, L.L.C.
Model TLPCHSTRP-REG
Device description REGARD TELEMETRY POUCH, BLUE/CLEAR, W/STRAP, DISPOSABLE
Published 2026-03-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name DSW Bag, Polymeric Mesh, Pacemaker
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSW Bag, Polymeric Mesh, Pacemaker Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20326053123539 Primary GS1 0 00326053123535 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20326053123539 20326053123539 00326053123535 00326053123535 326053123535 0326053123535
GMDN Terms# Term, Definition table Term Definition Personal device holder, single-use A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.
Regulatory Flags# DUNS number 134472476 Device count 100 Premarket exempt true Lot or batch true Manufacturing 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 20326053123522 Regard™ Resource Optimization & Innovation, L.L.C. DSW 2026-03-11 00326053123528 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. DSW 2026-03-11 00326053123535 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. DSW 2026-03-11 20680651718253 Halyard O&M HALYARD, INC. DSW 2020-11-16 20680651719007 Halyard O&M HALYARD, INC. DSW 2020-11-16 30680651718250 Halyard O&M HALYARD, INC. DSW 2020-11-16 30680651719004 Halyard O&M HALYARD, INC. DSW 2020-11-16 20680651718000 Halyard O&M HALYARD, INC. DSW 2020-08-31 30680651718007 Halyard O&M HALYARD, INC. DSW 2020-08-31 00801741040955 Bard® Parsonnet Pulse Generator Pouches Bard Peripheral Vascular, Inc. DSW 2015-09-25 00801741040962 Bard® Parsonnet Pulse Generator Pouches Bard Peripheral Vascular, Inc. DSW 2015-09-25 00801741040979 Bard® Parsonnet Pulse Generator Pouches Bard Peripheral Vascular, Inc. DSW 2015-09-25 10801741040952 Bard® Parsonnet Pulse Generator Pouches Bard Peripheral Vascular, Inc. DSW 2015-09-25 10801741040969 Bard® Parsonnet Pulse Generator Pouches Bard Peripheral Vascular, Inc. DSW 2015-09-25 10801741040976 Bard® Parsonnet Pulse Generator Pouches Bard Peripheral Vascular, Inc. DSW 2015-09-25