FDA.reportPublic FDA data

Regard™

Primary DI
20326053118511
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
BTNBLT-REG
Catalog number
BTNBLT-REG
Device description
Maternity Button Hole Fetal Belt, Iniv Size
Published
2023-08-10
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
CodeName
ISRBand Or Belt, Pelvic Support

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20326053118511PackageGS150In Commercial Distribution
10326053118514PrimaryGS10
00326053118517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2032605311851120326053118511
1032605311851410326053118514
00326053118517003260531185173260531185170326053118517

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, reusableA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134472476
Device count
2
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20326053123522Regard™TLPCHCLR-REG2026-03-11
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

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Primary DI, Brand, Company table
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04719879641868ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879641875ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879644562ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
00819567011233ComfytopiaComfytopia, Inc.ISR2025-07-09
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
00810113579122ViveVIVE HEALTH LLCISR2025-05-20
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10810113579129ViveVIVE HEALTH LLCISR2025-05-20
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00840252902086Therafit BeltsTherafin CorporationISR2023-07-06
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