FDA.reportPublic FDA data

ULTRAFLO-R

Primary DI
00857182006487
Brand
ULTRAFLO-R
Company
INNOVATIVE MEDICAL TECHNOLOGIES, INC
Model
364
Catalog number
364
Device description
PUSH BUTTON SAFETY BLOOD COLLECTION AND INFUSION SET 23GX3/4"X12" W LUER ADAPTER
Published
2025-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857182006484PrimaryGS10
00857182006487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085718200648410857182006484
00857182006487008571820064878571820064870857182006487

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8665201820SUPPORT@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
00857182006326ULTRAFLO-S2812025-02-14
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
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
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
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00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,Dynarex CorporationFPA2018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, SterileDynarex CorporationFPA2018-05-26