FDA.report

Regard™

Primary DI
20194717102431
Brand
Regard™
Company
ROI CPS, LLC
Model
AN01084
Published
2019-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OGDCustom Anesthesia Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717102431PackageGS15In Commercial Distribution
20194717106064PackageGS115In Commercial Distribution
10194717102434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471710243120194717102431
2019471710606420194717106064
1019471710243410194717102434

GMDN Terms

TermDefinition
Massage table/couch, non-powered, portableA manually-adjusted, portable table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It consists of a foldable framework (table top and legs) with a flat tabletop surface which may have a head section that can be manually adjusted. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may incorporate a face hole (the patients face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117174678
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20194717102295Regard™UR00857C2019-11-21
20194717120879Regard™HT01025G2024-12-20
20194717120886Regard™LD00090U2024-12-20
20194717120893Regard™HT00074Y2024-12-20
20194717120916Regard™GS00802N2024-12-20
20194717120923Regard™OR01102D2024-12-20
20194717120930Regard™OR01103D2024-12-20
20194717120947Regard™GY013302025-01-16
20194717120954Regard™GY013312025-01-16
20194717121098Regard™GU013212025-01-16
20194717116766Regard™OR011092023-01-25
20194717116773Regard™OR011132023-01-25
20194717116780Regard™OR011112023-01-26
20194717116797Regard™OR011142023-01-27
20194717116803Regard™OR011082023-01-27
20194717116810Regard™OR011072023-01-31
20194717118715Regard™OR01103B2024-02-09
20194717118722Regard™OR01102B2024-02-13
20194717100918Regard™OR00355E2019-12-23
20194717103124Regard™OR00095U2019-11-20

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