FDA.reportPublic FDA data

Bard® Parsonnet Pulse Generator Pouches

Primary DI
00801741040962
Brand
Bard® Parsonnet Pulse Generator Pouches
Company
Bard Peripheral Vascular, Inc.
Model
002905
Catalog number
002905
Device description
Bard® Parsonnet Pulse Generator Pouch, Large
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
10801741040969PackageGS15In Commercial Distribution
00801741040962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104096910801741040969
00801741040962008017410409628017410409620801741040962

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
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28

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
00801741040955Bard® 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