FDA.reportPublic FDA data

ULTRAFLO

Primary DI
50857182006000
Brand
ULTRAFLO
Company
Innovative Medical Technologies, Inc.
Model
281
Device description
"SAFETY BLOOD COLLECTION SET 21Gx3/4x12"""
Published
2018-09-11
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
60857182006007PackageGS110Not in Commercial Distribution
50857182006000PrimaryGS10
00857182006166Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6085718200600760857182006007
5085718200600050857182006000
00857182006166008571820061668571820061660857182006166

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
10857182006002INNOSET5961212016-06-06
10857182006026INNOSET5961252016-06-06
10857182006088QUICK-DRAW PLAIN ADAPTER15-9002016-08-05
10857182006170ULTRAFLO-S2832025-02-14

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Primary DI, Brand, Company table
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16972857299504PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299511PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299528PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299467PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-03
00613703823106EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
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00613703853608EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
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00840216124264LiteTouchAsp Global, LLCFMI2026-11-02
00840216123793LiteTouchAsp Global, LLCFMI2026-10-30
00840216123823LiteTouchAsp Global, LLCFMI2026-10-30
00840216123847LiteTouchAsp Global, LLCFMI2026-10-30
00840216124288LiteTouchAsp Global, LLCFMI2026-10-30
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09