FDA.reportPublic FDA data

ULTRAFLO-V

Primary DI
00857182006197
Brand
ULTRAFLO-V
Company
INNOVATIVE MEDICAL TECHNOLOGIES, INC
Model
607
Catalog number
607
Device description
SAFETY BLOOD COLLECTION NEEDLE 21GX1.25"
Published
2025-02-13
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172763000Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderZhejiang Kindly Medical Devices Co., Ltd.2018-06-04JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857182006203PrimaryGS10
00857182006197Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857182006203008571820062038571820062030857182006203
00857182006197008571820061978571820061970857182006197

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder/needleA sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. 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
48
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
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

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