FDA.reportPublic FDA data

ULTRAFLO-A

Primary DI
20857182006290
Brand
ULTRAFLO-A
Company
Innovative Medical Technologies, Inc.
Model
902
Catalog number
902
Device description
MALE LUER ACCESS DEVICE
Published
2025-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20857182006290PrimaryGS10
00857182006296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085718200629020857182006290
00857182006296008571820062968571820062960857182006296

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, noninvasiveA collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
8665201820SUPPORT@INNOVATIVEMEDTECH.COM

Regulatory Flags#

DUNS number
792740578
Device count
200
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850024924109Labcorp Comfort DrawMEDTOX DIAGNOSTICS, INC.KST2026-05-22
H671ABCTD0ABC TinyDrawUTAH MEDICAL PRODUCTS, INC.KST2025-09-18
00850033131116Enhanced HARegenlab USA LLCKST2025-08-29
00810185250509TherapakTherapak LLCKST2025-08-11
00810185250516TherapakTherapak LLCKST2025-08-11
04719875918100Transcend Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-08-07
20193489189664MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
30193489189661MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
10810100050457KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050587KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172676KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050078KBMEDKB Medical (group), Inc.KST2025-05-21
00850016172013KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050075KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050450KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050580KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172010KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050454KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050584KBMEDKB Medical (group), Inc.KST2025-05-21
20850016172673KBMEDKB Medical (group), Inc.KST2025-05-21
04719875918070Aeon Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
04719875918094Virtue Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
10888277415461MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
20888277415468MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
06974481839128Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974481839125Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
06974481839142Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974594960051N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960068N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960082N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01