FDA.reportPublic FDA data

Midline Catheter Kit

Primary DI
00801741108723
Brand
Midline Catheter Kit
Company
Bard Access Systems, Inc.
Model
P4153108
Catalog number
P4153108
Device description
3Fr SL PowerMidline catheter Full Kit
Published
2016-07-08
Public version status
Update
Distribution status
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
PNDMidline catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNDMidline CatheterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741108720PackageGS15In Commercial Distribution
00801741108723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174110872010801741108720
00801741108723008017411087238017411087230801741108723

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge3French
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741241055PowerPICC® Provena™ CatheterCK000909BCK000909B2026-10-29
00801741241062PowerPICC® Provena™ CatheterCK001006BCK001006B2026-10-29
00801741038204MicroEZ Introducer012894501289452016-02-08
00801741038211MicroEZ Introducer012895001289502016-02-08
00801741038228MicroEZ Introducer012896001289602016-02-08
00801741038235MicroEZ Introducer022894502289452016-02-08
00801741038242MicroEZ Introducer022895002289502016-02-08
00801741038259MicroEZ Introducer022896002289602016-02-08
00801741038266Peel-Apart Percutaneous Introducer Kit060111006011102016-02-22
00801741038273Peel-Apart Percutaneous Introducer Kit060111306011132016-02-22
00801741038280Peel-Apart Percutaneous Introducer Kit060111406011142016-02-22
00801741038297Peel-Apart Percutaneous Introducer Kit060111506011152016-02-22
00801741038303Peel-Apart Percutaneous Introducer Kit060115006011502016-02-22
00801741038310Peel-Apart Percutaneous Introducer Kit060116506011652016-02-22
00801741038327Peel-Apart Percutaneous Introducer Kit060117006011702016-02-22
00801741038334Peel-Apart Percutaneous Introducer Kit060771006077102016-02-22
00801741038341Peel-Apart Percutaneous Introducer Kit060777006077702016-02-22
00801741038358Peel-Apart Percutaneous Introducer Kit060778006077802016-02-22
00801741038365MicroEZ Introducer067893506789352016-02-08
00801741038372MicroEZ Introducer067894506789452016-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007787VYGONVygon CorporationPND2026-10-23
00849884007794VYGONVygon CorporationPND2026-10-23
00849884007800VYGONVygon CorporationPND2026-10-23
00849884007817VYGONVygon CorporationPND2026-10-23
00801741240904PowerMidlineBard Access Systems, Inc.PND2026-08-27
00849884007589VYGONVygon CorporationPND2026-06-25
00801741240102ProvenaBard Access Systems, Inc.PND2026-06-24
36927675517273SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517280SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517297SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517303SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517310SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675519857SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675519864SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520730SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520747SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520754SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
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