Progel™ Pleural Air Leak Sealant PGPS002
GUDID 10801741010023
Progel Pleural Air Leak Sealant
NEOMEND, INC.
Surgical adhesive/sealant, human-derived Surgical adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived| Primary Device ID | 10801741010023 |
| NIH Device Record Key | a3644c1f-3ed3-47f9-b3b9-ef452ca4c89b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Progel™ Pleural Air Leak Sealant |
| Version Model Number | PGPS002 |
| Catalog Number | PGPS002 |
| Company DUNS | 195251595 |
| Company Name | NEOMEND, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@crbard.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com | |
| Phone | +1(888)776-4351 |
| medical.services@bd.com |
Device Dimensions
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741010026 [Primary] |
| GS1 | 10801741010023 [Package] Contains: 00801741010026 Package: CA [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010047
FDA Product Code
| NBE | Sealant,polymerizing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-12 |
Devices Manufactured by NEOMEND, INC.
| 20801741010037 - Progel™ Applicator Spray Tips | 2019-11-08 Progel Applicator Spray Tips |
| 20801741099377 - Tridyne™ Vascular Sealant Standard Spray Tips | 2019-11-08 Tridyne Vascular Sealant Standard Spray Tips |
| 10801741010009 - Progel™Extended Applicator Spray Tip | 2019-11-08 Progel Extended Applicator Spray Tip |
| 10801741010016 - Progel™Extended Applicator Spray Tip | 2019-11-08 Progel Extended Applicator Spray Tip |
| 10801741099387 - Tridyne™ Vascular Sealant Extended Spray Tips | 2019-11-08 Tridyne Vascular Extended Tips, 6” |
| 10801741099363 - Tridyne™ Vascular Sealant | 2018-12-03 Tridyne Vascular Sealant |
| 10801741010023 - Progel™ Pleural Air Leak Sealant | 2018-07-06Progel Pleural Air Leak Sealant |
| 10801741010023 - Progel™ Pleural Air Leak Sealant | 2018-07-06 Progel Pleural Air Leak Sealant |
Trademark Results [Progel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGEL 86926507 not registered Live/Pending |
American Casein Company 2016-03-02 |
 PROGEL 85842976 4396175 Live/Registered |
American International Industries 2013-02-06 |
 PROGEL 85813171 4380136 Live/Registered |
FLOTEK CHEMISTRY, LLC 2012-12-31 |
 PROGEL 85733887 4334631 Dead/Cancelled |
National Dental Supply ARL LLC 2012-09-20 |
 PROGEL 85340359 4095936 Live/Registered |
Shimizu Chemical Corporation 2011-06-07 |
 PROGEL 79225209 5478109 Live/Registered |
Real Good Food Plc 2017-05-31 |
 PROGEL 78419320 3053306 Dead/Cancelled |
Wilderness Trail Bikes Licensing, Inc. 2004-05-14 |
 PROGEL 77283727 3811322 Live/Registered |
Neomend, Inc. 2007-09-19 |
 PROGEL 75693012 2418369 Dead/Cancelled |
PROFESSIONAL PACKAGING, INC. 1999-04-28 |
 PROGEL 74719193 not registered Dead/Abandoned |
Advanced Nutritionals Corporation 1995-08-23 |
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