FDA.reportPublic FDA data

INNOVATE MEDICAL

Primary DI
10852937003022
Brand
INNOVATE MEDICAL
Company
INNOVATE MEDICAL, LLC
Model
10-2000-01
Catalog number
10-2000-01
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
Rx
false
OTC
true
Sterile
false
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
10852937003022PackageGS120In Commercial Distribution
00852937003025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085293700302210852937003022
00852937003025008529370030258529370030250852937003025

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

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
00852937003018INNOVATE MEDICAL10-1001-0410-1001-042022-11-14
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