FDA.reportPublic FDA data

IV Pole Cart, M3000

Primary DI
00850039020063
Brand
IV Pole Cart, M3000
Company
Medical Technical Products, Inc.
Model
551-0052-001
Published
2023-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080803000VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551American Optisurgical, Inc.2008-09-22HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039020063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039020063008500390200638500390200630850039020063

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous poleA metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Commonly known as an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed or operating table, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels to allow patient mobility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)551-4762service@medtechprods.com

Regulatory Flags#

DUNS number
151291010
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039020001Console, M2000, Value02-90222023-02-15
00850039020018Console, M2000, Enhanced23-90232023-02-15
00850039020025Console, M2000, Premium02-90282023-02-15
00850039020032Footpedal, M2000, Herga48-90492023-02-15
00850039020049Footpedal, M2000, MTP48-92102023-02-15
00850039020056Console, M3000551-0034-0012023-02-15
00850039020070Footpedal, M3000, MTP553-0001-0012023-02-15
00850039020087US Handpiece, Standard01-8991452023-02-15
00850039020094US Handpiece, Standard, Meda01-8992462023-02-15
00850039020100US Handpiece, Mini01-8995302023-02-15
00850039020117US Handpiece, Vizual300-9500-2702023-02-15
00850039020124IA Handpiece23-90002023-02-15
00850039020131Aspiration Tip, .3mm, Straight23-90012023-02-15
00850039020148Aspiration Tip, .3mm, 45DEG23-90022023-02-15
00850039020155Irrigation Sleeve, 19GA, Pack 523-90032023-02-15
00850039020162Test Chamber, Pack 523-90042023-02-15
00850039020179Vitrector, M2000, 20GA23-90052023-02-15
00850039020186Vitrector, M3000, 20GA23-90062023-02-15
00850039020193Tubing Kit, M200023-90162023-02-15
00850039020209Irrigation Sleeve, 20GA, Pack 523-90212023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380657530274LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530281LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530298LEGION, INTREPIDAlcon Laboratories, Inc.HQC2026-07-22
00380657530373LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530502LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530564LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530755LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657531639LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531646LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531653LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531660LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31