FDA.reportPublic FDA data

ULTRAFLO-S

Primary DI
00857182006326
Brand
ULTRAFLO-S
Company
INNOVATIVE MEDICAL TECHNOLOGIES, INC
Model
281
Device description
SAFETY BLOOD COLLECTION SET 21Gx3/4x12"
Published
2025-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10857182006323PrimaryGS10
00857182006326Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085718200632310857182006323
00857182006326008571820063268571820063260857182006326

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
792740578
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857182006692ULTRAFLO-S2962962025-04-03
00857182006708ULTRAFLO-S2982982025-04-03
00857182006173ULTRAFLO-S2832025-02-14
00857182006289ULTRAFLO-T8108102025-02-14
00857182006296ULTRAFLO-A9029022025-02-14
00857182006333ULTRAFLO-S2852025-02-14
00857182006197ULTRAFLO-V6076072025-02-13
00857182006258ULTRAFLO-R3383382025-02-13
00857182006616ULTRAFLO-R3363362025-02-13
00857182006654ULTRAFLO-R3353352025-02-13
00857182006227ULTRAFLO-V6086082025-02-13
00857182006319ULTRAFLO-S2922922025-02-13
00857182006432ULTRAFLO-S6566562025-02-13
00857182006470ULTRAFLO-R3633632025-02-13
00857182006487ULTRAFLO-R3643642025-02-13
00857182006494ULTRAFLO-R3653652025-02-13
00857182006500ULTRAFLO-R6876872025-02-13
00857182006548ULTRAFLO-S2962962025-02-13
00857182006555ULTRAFLO-S2972972025-02-13
00857182006562ULTRAFLO-S2982982025-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11