FDA.reportPublic FDA data

Convenience Kit

Primary DI
00628942939754
Brand
Convenience Kit
Company
InnovaRXI Ltd.
Model
CK003
Device description
Kit Contents:1- Pair of Nitrile Examination Gloves1- Cardiopulmonary Resuscitation (CPR) Mask
Published
2025-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628942939754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628942939754006289429397546289429397540628942939754

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
242446823
Device count
1
Premarket exempt
true
Kit
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
10885380211195Aero-MedAERO-MED, LLCKDD2026-02-13
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10885380208515Aero-MedAERO-MED, LLCKDD2025-06-19
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10885380195365Aero-MedAERO-MED, LLCKDD2023-04-20
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10885380194733Aero-MedAERO-MED, LLCKDD2023-02-24
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15