FDA.reportPublic FDA data

INNOVATE MEDICAL

Primary DI
00852937003018
Brand
INNOVATE MEDICAL
Company
INNOVATE MEDICAL, LLC
Model
10-1001-04
Catalog number
10-1001-04
Device description
Blood Culture Kit
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFMPhlebotomy Blood Collection Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFMPhlebotomy Blood Collection KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852937003015PackageGS120In Commercial Distribution
00852937003018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085293700301510852937003015
00852937003018008529370030188529370030180852937003018

GMDN Terms#

Term, Definition table
TermDefinition
Blood culture broth kit IVDA collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4234613558QA@innovatemed.com

Regulatory Flags#

DUNS number
050339980
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852937003087HCTHCT9849-12023-03-17
00852937003070HCTHCTBBD-1002023-08-08
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
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
10198956292130CARDINAL HEALTHCardinal Health 200, LLCOFM2026-02-12
10198956234901CARDINAL HEALTHCardinal Health 200, LLCOFM2026-01-15
50198956234909CARDINAL HEALTHCardinal Health 200, LLCOFM2026-01-15
10809160505342Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-12-02
20809160505349Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-12-02
10809160501276Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-10-30
00852714003224Aurix Nuo Therapeutics, Inc.OFM2025-10-06
10198956207639CARDINAL HEALTHCardinal Health 200, LLCOFM2025-09-29
50198956207637CARDINAL HEALTHCardinal Health 200, LLCOFM2025-09-29
10198956062696CARDINAL HEALTHCardinal Health 200, LLCOFM2025-05-29
50198956062694CARDINAL HEALTHCardinal Health 200, LLCOFM2025-05-29
10809160466605Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
20809160466602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
10809160460719Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-18
20809160460716Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-18
10809160460207Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-12
20809160460204Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-12
00860009842274Straight Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
00860009842281Butterfly Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
10809160432501Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
20809160432508Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
10809160424421Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
20809160424428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
10194717117827Regard™ROI CPS, LLCOFM2023-09-29
20194717117824Regard™ROI CPS, LLCOFM2023-09-29
20194717117831Regard™ROI CPS, LLCOFM2023-09-29
10809160403327Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2023-06-23
20809160403324Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2023-06-23
00852714003187Aurix XLNuo Therapeutics, Inc.OFM2023-03-27
00852937003025INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14