FDA.reportPublic FDA data

APLICOR 3D, Dr. INVIVO

Primary DI
00889692501015
Brand
APLICOR 3D, Dr. INVIVO
Company
ROKIT HEALTHCARE Inc.
Model
4D2D101
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889692501015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889692501015008896925010158896925010150889692501015

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory liquid dispenser, electronicAn electronic laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The intended volume is normally user-selected prior to the delivery of the liquid. The device typically has a peristaltic pump for delivery of the preselected volume that typically ranges from 1 ml to 9.99 L. This device can be user operated, automatic, or programmable.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689004656
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809692500285Dr.INVIVO4D2D1012026-04-02
08809692501015APLICOR 3D4D2D1012024-10-04
08809692500117APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0012024-10-04
08809692500131APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0032024-10-04
08809692500124APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0022024-10-04
08809692507000AiD RegenAIDR-0012024-11-14
00889692500117APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0012024-10-04
00889692500124APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0022024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20
10827989000398Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989004167Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989000336Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000343Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000350Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000770Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004044Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004051Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004068Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989001098Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001128Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001159Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001180Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001210Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001241Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001272Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001302Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001333Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16