FDA.reportPublic FDA data

INNOSET

Primary DI
10857182006002
Brand
INNOSET
Company
Innovative Medical Technologies, Inc.
Model
596121
Device description
SAFETY BLOOD COLLECTION SET 21G
Published
2016-06-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
20857182006009PackageGS14Not in Commercial Distribution
10857182006002PrimaryGS10
00857182006005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085718200600920857182006009
1085718200600210857182006002
00857182006005008571820060058571820060050857182006005

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge21Gauge

Contacts#

Phone, Email table
PhoneEmail
866-560-1820support@innovativemedtech.com

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
10857182006330UltraFlo-S2852026-03-12
20857182006337ULTRAFLO-S2852025-02-14
00857182006784UltraFlo-C6810052025-12-30
00857182006807UltraFlo-C6820052025-12-30
10857182006026INNOSET5961252016-06-06
10857182006088QUICK-DRAW PLAIN ADAPTER15-9002016-08-05
10857182006170ULTRAFLO-S2832025-02-14
10857182006224ULTRAFLO-V6086082025-02-13

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