Home GUDID 00326053123528 Regard™
Primary DI 00326053123528
Brand Regard™
Company RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model TLPCHCLR-REG
Device description REGARD TELEMETRY POUCH, CLEAR, CLIP, DISPOSABLE
Published 2026-03-11
Public version status New
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 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 20326053123522 Primary GS1 0 00326053123528 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 20326053123522 20326053123522 00326053123528 00326053123528 326053123528 0326053123528
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, strap, belt, or clothing. This is a single-use device.
Regulatory Flags# DUNS number 134472476 Device count 100 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false 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 20326053123522 Regard™ Resource Optimization & Innovation, L.L.C. DSW 2026-03-11 20326053123539 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