FDA.report

Regard™

Primary DI
20194717102417
Brand
Regard™
Company
ROI CPS, LLC
Model
OB01054B
Published
2019-11-15
Public version status
New
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
MLSLabor And Delivery Kit

Product Code Classifications

CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717102417PackageGS110In Commercial Distribution
10194717102410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471710241720194717102417
1019471710241010194717102410

GMDN Terms

TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956420531CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956421040CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956417753CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956419818CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420760CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956427820CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956310092CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956393774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956407365CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956408805CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956413946CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956318609CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956401363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956414950CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956418774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956278064CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956313925CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408706CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408959CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411416CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411775CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956366099CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09
50198956396492CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09
50198956403916CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09
50198956365641CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-06
50198956402605CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-06
50198956404630CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-06
50198956403466CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-03