FDA.reportPublic FDA data

Progel

Primary DI
00801741010019
Brand
Progel
Company
NEOMEND, INC.
Model
PGEN005-11
Catalog number
PGEN005-11
Device description
Progel, Pleural Air Leak Sealant, Extended Applicator Spray Tip, 29 cm
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
10801741010016PackageGS14In Commercial Distribution
00801741010019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101001610801741010016
00801741010019008017410100198017410100190801741010019

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length29Centimeter

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741010026ProgelPGPS002PGPS0022014-09-12
00801741099366TridyneTDVS004TDVS0042018-10-31
10801741010030ProgelPGST009PGST0092014-09-12
10801741099370TridyneTDST0020TDST00202018-10-31
00801741010002ProgelPGEN005-06PGEN005-062014-09-12
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