Regard™

Primary DI
20326053123522
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
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
CodeName
DSWBag, Polymeric Mesh, Pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSWBag, Polymeric Mesh, PacemakerCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20326053123522PrimaryGS10
00326053123528Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2032605312352220326053123522
00326053123528003260531235283260531235280326053123528

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11
10326053118231Regard™CHMG38GNS800M-REGCHMG38GNS800M-REG2023-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20326053123539Regard™Resource Optimization & Innovation, L.L.C.DSW2026-03-11
00326053123528Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.DSW2026-03-11
00326053123535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.DSW2026-03-11
20680651718253HalyardO&M HALYARD, INC.DSW2020-11-16
20680651719007HalyardO&M HALYARD, INC.DSW2020-11-16
30680651718250HalyardO&M HALYARD, INC.DSW2020-11-16
30680651719004HalyardO&M HALYARD, INC.DSW2020-11-16
20680651718000HalyardO&M HALYARD, INC.DSW2020-08-31
30680651718007HalyardO&M HALYARD, INC.DSW2020-08-31
00801741040955Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
00801741040962Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
00801741040979Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040952Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040969Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040976Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25