FDA.reportPublic FDA data

Vizient Novaplus

Primary DI
50749756804696
Brand
Vizient Novaplus
Company
DEROYAL INDUSTRIES, INC.
Model
VM8125-I
Catalog number
VM8125-I
Device description
IV ARMBOARD
Published
2021-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMKDEVICE, INTRAVASCULAR CATHETER SECUREMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756804696PackageGS130In Commercial Distribution
00749756804691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975680469650749756804696
00749756804691007497568046917497568046910749756804691

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
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
true
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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430004283935FlexGRIPBedalKMK2025-12-19
05430000258494FlexGRIPBedalKMK2025-12-03
05430000258654Bedal BedalKMK2025-12-03
05430003674017FlexGRIPBedalKMK2025-12-03
05430003674062FlexGRIPBedalKMK2025-12-03
05430003674239Bedal BedalKMK2025-12-03
05430003674260Bedal BedalKMK2025-12-03
05430004283812Bedal BedalKMK2025-12-03
05430003674116FlexGRIPBedalKMK2025-12-02
05430003674147FlexGRIPBedalKMK2025-12-02
05430003674321FlexGRIPBedalKMK2025-12-02
05430003674468FlexGRIPBedalKMK2025-12-02
05430003674499FlexGRIPBedalKMK2025-12-02
05430003674956FlexGRIPBedalKMK2025-12-02
05430003674987FlexGRIPBedalKMK2025-12-02
05430004283270FlexGRIPBedalKMK2025-12-02
05430004283355FlexGRIPBedalKMK2025-12-02
05430004283386FlexGRIPBedalKMK2025-12-02
05430004283416FlexGRIPBedalKMK2025-12-02
05430004283447FlexGRIPBedalKMK2025-12-02
05430004283478FlexGRIPBedalKMK2025-12-02
05430004283553FlexGRIPBedalKMK2025-12-02
05430004283584FlexGRIPBedalKMK2025-12-02
05430004283737FlexGRIPBedalKMK2025-12-02
05430004283768FlexGRIPBedalKMK2025-12-02
05430004283867FlexGRIPBedalKMK2025-12-02
05430000258173Bedal BedalKMK2025-12-01
05430000258258FlexGRIPBedalKMK2025-12-01
05430003674178FlexGRIPBedalKMK2025-12-01
05430003674208FlexGRIPBedalKMK2025-12-01