FDA.reportPublic FDA data

PowerGlide ST

Primary DI
10801741226882
Brand
PowerGlide ST
Company
Bard Access Systems, Inc.
Model
PCK00015
Catalog number
PCK00015
Device description
Catheter Placement Kit
Published
2023-06-19
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
PNDMidline catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNDMidline CatheterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741226882PackageGS16In Commercial Distribution
00801741226885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174122688210801741226882
00801741226885008017412268858017412268850801741226885

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
Length8Centimeter
Needle Gauge20Gauge

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
00801741036712Groshong771070077107002015-09-24
00801741036729Groshong771155077115502015-09-24
00801741037696Groshong772495077249502015-09-24
00801741037719Groshong774155077415502015-09-24
10801741239356PowerPICC Sherlock 3CGCK001067ACK001067A2026-03-11
10801741239363PowerPICC ProvenaCK001068ACK001068A2026-03-11
10801741239370PowerPICC ProvenaCK001069ACK001069A2026-03-11
10801741239271MiniLocCPA00072CPA000722026-02-26
10801741238830PowerPICC Provena SOLOCK001091CK0010912026-02-11
00801741038464Niagara Slim-Cath catheter543215054321502015-12-04
00801741038471Niagara Slim-Cath Catheter543220054322002015-11-20
00801741038488Niagara Slim-Cath catheter543224054322402015-12-04
00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007510VYGONVygon CorporationPND2026-05-22
00849884007527VYGONVygon CorporationPND2026-05-22
50884908185718CT MIDLINE CATHETERMedical Components, Inc.PND2026-01-15
30849884007030VYGONVygon CorporationPND2025-09-26
30849884007047VYGONVygon CorporationPND2025-09-25
30849884006941VYGONVygon CorporationPND2025-09-15
30849884007009VYGONVygon CorporationPND2025-09-05
30849884006996VYGONVygon CorporationPND2025-08-21
10801741236140ProvenaBard Access Systems, Inc.PND2025-08-20
10801741236157ProvenaBard Access Systems, Inc.PND2025-08-20
10801741236836PowerMidlineBard Access Systems, Inc.PND2025-08-20
10801741234849Provena MidlineBard Access Systems, Inc.PND2025-01-23
10801741234566PowerMidlineBard Access Systems, Inc.PND2024-12-09
10801741234597Provena MidlineBard Access Systems, Inc.PND2024-12-09
10801741232135PowerMidlineBard Access Systems, Inc.PND2024-09-27
10801741232142Bard PowerMidlineBard Access Systems, Inc.PND2024-09-27
10801741233224Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233231Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233248Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233255Provena MidlineBard Access Systems, Inc.PND2024-09-27
20801902213062ARROWTELEFLEX INCORPORATEDPND2024-08-01
20801902213086ARROWTELEFLEX INCORPORATEDPND2024-08-01
1085004236505920G 8CM Stiletto Extended Dwell CatheterAvia Vascular, LLCPND2024-06-25
0085005184200120G 8CM Stiletto Extended Dwell CatheterSlipstream Medical, LLCPND2024-02-05
20801902218869ARROWTELEFLEX INCORPORATEDPND2024-01-29
20801902218852ARROWTELEFLEX INCORPORATEDPND2024-01-24
10801741226943PowerMidlineBard Access Systems, Inc.PND2023-09-19
20801902216827ARROWTELEFLEX INCORPORATEDPND2023-09-13
20801902216834ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801741227544ProvenaBard Access Systems, Inc.PND2023-07-10