FDA.reportPublic FDA data

Manan Medical Products, Inc.

Primary DI
00859013006116
Brand
Manan Medical Products, Inc.
Company
MANAN MEDICAL PRODUCTS, INC.
Model
502505
Catalog number
502505
Device description
"Vascular Access Needle19GA.SP x 2.75"""
Published
2016-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851834000MANAN GWI GUIDE WIRE INTRODUCERManan Manufacturing Co., Inc.1985-07-11DWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859013006113PackageGS130Not in Commercial Distribution
20859013006110PackageGS13Not in Commercial Distribution
00859013006116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085901300611310859013006113
2085901300611020859013006110
00859013006116008590130061168590130061160859013006116

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.75Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
224-625-8331David.Gasparik@argonmedical.com

Regulatory Flags#

DUNS number
831737957
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859013006031Medistar/Hatch (Private Label)FNM-2205-UGFNM-2205-UG2016-10-14
00859013006109Manan Medical Products, Inc.5025025025022016-10-26
00859013006123Manan Medical Products, Inc.5025065025062016-10-26
00859013006130Manan Medical Products, Inc.5025075025072016-10-26
00859013006147Manan Medical Products, Inc.5025145025142016-10-26
00859013006154Manan Medical Products, Inc.5026525026522016-10-26
00859013006161Manan Medical Products, Inc.GWI1802EUSGWI1802EUS2016-10-26
00859013006178Manan Medical Products, Inc.GWI1802EWWGWI1802EWW2016-10-26
00859013006185Manan Medical Products, Inc.GWI20015EWWGWI20015EWW2016-10-26
00859013006079MPM Medical Supply (Private Label)LBN-2020LBN-20202017-01-05
00859013006017MPM Medical Supply (Private Label)KOP2003KOP20032017-01-05
00859013006024MPM Medical Supply (Private Label)KOP2005KOP20052017-01-12
00859013006048Midwest Medical Inc. (Private Label)CNM2206-MMCNM2206-MM2016-09-21
00859013006055MPM Medical Supply (Private Label)KOP2007KOP20072017-01-05
00859013006062MPM Medical Supply (Private Label)KOP2010KOP20102017-01-05
00859013006093MPM Medical Supply (Private Label)TNL0815TNL08152017-01-05
00859013006000MPM Medical Supply (Private Label)BMNJ-MEC-1110BMNJ-MEC-11102017-01-12
20859013006011MPM Medical Supply (Private Label)KOP2003KOP20032017-01-05
20859013006028MPM Medical Supply (Private Label)KOP2005KOP20052017-01-12
20859013006035Medistar/Hatch (Private Label)FNM-2205-UGFNM-2205-UG2016-10-14

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