FDA.reportPublic FDA data

HCT

Primary DI
00852937003070
Brand
HCT
Company
INNOVATE MEDICAL, LLC
Model
HCTBBD-100
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYWContainer, Liquid Medication, Graduated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852937003077PackageGS120In Commercial Distribution
00852937003070PrimaryGS10
00382903083411Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085293700307710852937003077
00852937003070008529370030708529370030700852937003070
00382903083411003829030834113829030834110382903083411

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted protective capA small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050339980
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852937003087HCTHCT9849-12023-03-17
00852937003025INNOVATE MEDICAL10-2000-0110-2000-012022-11-14
00852937003032INNOVATE MEDICAL9-204099-204092022-11-14
00852937003049INNOVATE MEDICAL9-204129-204122022-11-14
00852937003056INNOVATE MEDICAL9-206099-206092022-11-14
00852937003063INNOVATE MEDICAL9-206129-206122022-11-14
00852937003278INNOVATE MEDICAL820-5409820-54092022-11-14
00852937003285INNOVATE MEDICAL820-5412820-54122022-11-14
00852937003292INNOVATE MEDICAL820-5609820-56092022-11-14
00852937003308INNOVATE MEDICAL820-5612820-56122022-11-14
00852937003018INNOVATE MEDICAL10-1001-0410-1001-042022-11-14
10852937003022INNOVATE MEDICAL10-2000-0110-2000-012022-11-14
10852937003039INNOVATE MEDICAL9-204099-204092022-11-14
10852937003046INNOVATE MEDICAL9-204129-204122022-11-14
10852937003053INNOVATE MEDICAL9-206099-206092022-11-14
10852937003060INNOVATE MEDICAL9-206129-206122022-11-14
10852937003275INNOVATE MEDICAL820-5409820-54092022-11-14
10852937003282INNOVATE MEDICAL820-5412820-54122022-11-14
10852937003299INNOVATE MEDICAL820-5609820-56092022-11-14
10852937003305INNOVATE MEDICAL820-5612820-56122022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008021Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008038Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008045Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008052Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989007901Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007918Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007925Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007932Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007907Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007914Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007921Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
30815112021444Mixing ContainerBracco Diagnostics Inc.KYW2026-01-09
16931918145068AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
00661392002180LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00661392012332LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00840306835988Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2025-01-16
00840306836008Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2025-01-16
10827989003467Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003474Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003481Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003498Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
00616784425238Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00810180844918Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
10653160381464MEDLINEMEDLINE INDUSTRIES, INC.KYW2024-10-18
16931918172811AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2024-09-05
00852359007403CrushieldMAXPERT MEDICALKYW2024-05-13
10827989002095Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16
10827989002101Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16
10827989002118Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16