FDA.reportPublic FDA data

Bard® Parsonnet Pulse Generator Pouches

Primary DI
00801741040955
Brand
Bard® Parsonnet Pulse Generator Pouches
Company
Bard Peripheral Vascular, Inc.
Model
002904
Catalog number
002904
Device description
Bard® Parsonne Pulse Generator Pouch, Small
Published
2015-09-25
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
DSWBAG, POLYMERIC MESH, PACEMAKER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSWBag, Polymeric Mesh, PacemakerCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741040952PackageGS15In Commercial Distribution
00801741040955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104095210801741040952
00801741040955008017410409558017410409550801741040955

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pulse generator mesh bag, non-bioabsorbableAn implantable woven/knitted or porous bag made from a non-bioabsorbable synthetic polymer(s) intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator) to stabilize the implant in the subcutaneous pocket in which it is implanted; it does not contain an antimicrobial agent.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741067877Seeker®SK13514SK135142016-05-31
00801741067884Seeker®SK13518SK135182016-05-31
00801741067891Seeker®SK13535MSK13535M2016-05-31
00801741067907Seeker®SK15014SK150142016-05-31
00801741067914Seeker®SK15018SK150182016-05-31
00801741067921Seeker®SK15035MSK15035M2016-05-31
00801741067938Seeker®SK6535MSK6535M2016-05-31
00801741067945Seeker®SK9018SK90182016-05-31
00801741067952Seeker®SK9035MSK9035M2016-05-31
00801741201271ReconSCCTO110ASCCTO110A2021-10-04
00801741201288ReconSCCTO110SCCTO1102021-10-04
00801741201295ReconSCCTO110ATSCCTO110AT2021-10-04
00801741201301ReconSCCTO110TSCCTO110T2021-10-04
00801741182754WavelinQW04200W042002019-02-22
00801741067792SIDEKICK®SD110SD1102016-09-13
00801741067808SIDEKICK®SD110ASD110A2016-09-13
00801741067815SIDEKICK®SD110ATSD110AT2016-09-13
00801741067822SIDEKICK®SD110TSD110T2016-09-13
00801741067839SIDEKICK®SD70SD702016-09-13
00801741067846SIDEKICK®SD70ASD70A2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20326053123522Regard™Resource Optimization & Innovation, L.L.C.DSW2026-03-11
20326053123539Regard™Resource Optimization & Innovation, L.L.C.DSW2026-03-11
00326053123528Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.DSW2026-03-11
00326053123535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.DSW2026-03-11
20680651718253HalyardO&M HALYARD, INC.DSW2020-11-16
20680651719007HalyardO&M HALYARD, INC.DSW2020-11-16
30680651718250HalyardO&M HALYARD, INC.DSW2020-11-16
30680651719004HalyardO&M HALYARD, INC.DSW2020-11-16
20680651718000HalyardO&M HALYARD, INC.DSW2020-08-31
30680651718007HalyardO&M HALYARD, INC.DSW2020-08-31
00801741040962Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
00801741040979Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040952Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040969Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040976Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25