FDA.reportPublic FDA data

Progel

Primary DI
00801741010026
Brand
Progel
Company
NEOMEND, INC.
Model
PGPS002
Catalog number
PGPS002
Device description
Progel, Pleural Air Leak Sealant, 4 ml Kit
Published
2014-09-12
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
NBESealant,polymerizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBESealant, PolymerizingUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741010023PackageGS14In Commercial Distribution
00801741010026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101002310801741010023
00801741010026008017410100268017410100260801741010026

GMDN Terms#

Term, Definition table
TermDefinition
Surgical internal adhesive/sealant, human-derivedA bioabsorbable substance containing human-derived material [e.g., human serum albumin (HSA)] intended to be used for internal surgical applications to bond or seal cut, incised, or resected body tissues typically as an adjunct to standard methods of closure, to seal leaks, and might in addition be intended to achieve haemostasis through tissue sealing. Disposable mixing devices/applicators may be included for preparation and application to anatomical sites. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)776-4351medical.services@bd.com

Regulatory Flags#

DUNS number
195251595
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741099366TridyneTDVS004TDVS0042018-10-31
10801741010030ProgelPGST009PGST0092014-09-12
10801741099370TridyneTDST0020TDST00202018-10-31
00801741010002ProgelPGEN005-06PGEN005-062014-09-12
00801741010019ProgelPGEN005-11PGEN005-112014-09-12
00801741099380TridyneTDET0006TDET00062018-10-31
20801741010037Progel™ Applicator Spray TipsPGST009PGST0092014-09-12
20801741099377Tridyne™ Vascular Sealant Standard Spray TipsTDST0020TDST00202018-10-31
10801741010009Progel™Extended Applicator Spray TipPGEN005-06PGEN005-062014-09-12
10801741010016Progel™Extended Applicator Spray TipPGEN005-11PGEN005-112014-09-12
10801741099387Tridyne™ Vascular Sealant Extended Spray TipsTDET0006TDET00062018-10-31
10801741099363Tridyne™ Vascular SealantTDVS004TDVS0042018-10-31
10801741010023Progel™ Pleural Air Leak SealantPGPS002PGPS0022014-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05413765583520PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
05413765583582PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
25413765583524PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
25413765583586PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
05413765583599PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
05413765583605PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
25413765583593PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
25413765583609PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
05413765583414COSEAL SPRAY SETBAXTER HEALTHCARE CORPORATIONNBE2020-09-30
35413765583415COSEAL SPRAY SETBAXTER HEALTHCARE CORPORATIONNBE2020-09-30
10801741099370TridyneNEOMEND, INC.NBE2018-10-31
00801741099366TridyneNEOMEND, INC.NBE2018-10-31
00801741099380TridyneNEOMEND, INC.NBE2018-10-31
20801741099377Tridyne™ Vascular Sealant Standard Spray TipsNEOMEND, INC.NBE2018-10-31
10801741099363Tridyne™ Vascular SealantNEOMEND, INC.NBE2018-10-31
10801741099387Tridyne™ Vascular Sealant Extended Spray TipsNEOMEND, INC.NBE2018-10-31
00085412083322Coseal Surgical Sealant Replacement ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
50085412083327Coseal Surgical Sealant Replacement ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
00085412083339Coseal Surgical Sealant Extended ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
00085412087788Coseal Spray SetBaxter Healthcare SANBE2017-03-23
00850868002049PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2015-12-31
00850868002056PreveLeak™ 10 pack TipsTenaxis Medical, Inc.NBE2015-12-31
05413765404627Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-06-10
05413765404634Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-05-05
05413765404610Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-05-04
10705031133105ETHICON OMNEXEthicon Inc.NBE2014-09-20
30705031133109ETHICON OMNEXETHICON INC.NBE2014-09-20
00850868002025PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
00850868002032PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
00850868002063PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15