FDA.reportPublic FDA data

UltraFlo-S

Primary DI
10857182006330
Brand
UltraFlo-S
Company
Innovative Medical Technologies, Inc.
Model
285
Device description
"SAFETY BLOOD COLLECTION SET 25GX3/4X12"""
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857182006330PrimaryGS10
00857182006333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085718200633010857182006330
00857182006333008571820063338571820063330857182006333

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Regulatory Flags#

DUNS number
792740578
Device count
50
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
10857182006477ULTRAFLO-R3633632025-02-13
10857182006484ULTRAFLO-R3643642025-02-13
10857182006491ULTRAFLO-R3653652025-02-13
10857182006507ULTRAFLO-R6876872025-02-13
10857182006576ULTRAFLO-R3233232025-02-13
10857182006583ULTRAFLO-R3243242025-02-13
10857182006590ULTRAFLO-R3263262025-02-13
40857182006508ULTRAFLO-R6886882025-02-13
70857182006509ULTRAFLO-R6896892025-02-13
00857182006265ULTRAFLO-R3383382025-02-13
00857182006623ULTRAFLO-R3363362025-02-13
00857182006661ULTRAFLO-R3353352025-02-13
20857182006337ULTRAFLO-S2852025-02-14
00857182006784UltraFlo-C6810052025-12-30
00857182006807UltraFlo-C6820052025-12-30
10857182006002INNOSET5961212016-06-06
10857182006026INNOSET5961252016-06-06
10857182006088QUICK-DRAW PLAIN ADAPTER15-9002016-08-05
10857182006170ULTRAFLO-S2832025-02-14
10857182006224ULTRAFLO-V6086082025-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
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08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
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08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03