FDA.reportPublic FDA data

Dual Spike infiltration tubing

Primary DI
00850000712270
Brand
Dual Spike infiltration tubing
Company
Millennium Medical Technologies, Inc.
Model
IT-10002
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000712270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000712270008500007122708500007122700850000712270

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968286021
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLC-10250H2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLC-10500H2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLC-101000H2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLC-102000H2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLC-103000H2026-01-29
00850000712119Disposable Fat Extraction cannula 3.4dis X 20cmMMT-D-100-202023-08-07
00850000712140Disposable Milli SuperG cannula 3.4mm X 20cm longMMT-D-100-3008500007121402023-08-07
00850000712164Disposable SuperG mini cannula 2.5mm X 20cm long, 12 holeMMT-D-100-52023-08-07
00850000712171Disposable cannula 2.5mm dia C 20cm long, 3 slotsMMT-D-100-62023-08-07
00850000712188Disposable cannula 2.0mm X 20cm long, 6 spiral slotsMMT-D-100-72023-08-07
00850000712195Disposable cannula 14ga X 10cm cupMMT-D-100-82023-08-07
00850000712249Super G Micro cannula 2.5mm X 250mm long, 300 holesMMT-D-SGM-252502023-08-07
00850000712157MMTIntellifat2023-06-12
00850000712201AirSculpt ConsoleAIRS-12025-06-04
00850000712379AirSculpt HandpieceAS-HP-100002025-06-04
00850000712430AirSculpt Triple-Port TubingAS-80002025-06-04
00850000712331AirSculpt SystemAIRS-1-SYS2025-06-03
00850000712461AirSculpt Air Hose (IN)TD-100102025-06-03
00850000712423Acquicell ProCMXPRO-5002025-04-24
00850000712096Infiltration Large Bore TubingFAT-10002-IN2023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H787TDST0AngioDynamicsAngiodynamics, Inc.KGZ2026-06-04
00840329837389BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08
10850005416071MedDrainARMM INC.KGZ2023-06-08