Bolin Chest Seal BCS01

GUDID M689BCS01040

1 ea - Valved Hydrogel Dressing / 1 ea - Gauze Pad INTENDED USE: FOR THE INITIAL MANAGEMENT OF PENETRATING CHEST INJURIES

Safeguard US Operating, LLC

Pneumothorax dressing
Primary Device IDM689BCS01040
NIH Device Record Key91e907df-b80e-49a7-8803-3d55dc50cd2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBolin Chest Seal
Version Model Number04
Catalog NumberBCS01
Company DUNS118492643
Company NameSafeguard US Operating, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM689BCS01040 [Primary]

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

Devices Manufactured by Safeguard US Operating, LLC

M68924100070 - Poolside Medical Rescue Set 2025-01-20 Set provides medical support for bleeding control and wound care to facilitate injuries that may happen in or around pools, or a
M6898011010040 - 80-110-10 Saline Lock Kit Case of 102025-01-20 The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in on
M68980110140 - SALINE LOCK KIT2025-01-20 The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in on
M689BH01010 - Blizzard Casualty Blanket XL + Heat pads2025-01-14 Blizzard Blanket with Heat Pads
M68980100140 - INTRAVENOUS INFUSION STARTER SET 2025-01-06 The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in o
M6898010020030 - INTRAVENOUS INFUSION STARTER SET Case of 202025-01-06 The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in o
M68980110130 - SALINE LOCK KIT2024-12-20 The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in on
M689GOIO040 - GO IO Intraosseous Start Kit 12/Case2024-12-20 Secure IV and NIO Fixation

Trademark Results [Bolin Chest Seal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOLIN CHEST SEAL
BOLIN CHEST SEAL
85144930 3939318 Live/Registered
H&H MEDICAL CORPORATION
2010-10-05
BOLIN CHEST SEAL
BOLIN CHEST SEAL
85067580 not registered Dead/Abandoned
H&H Associates, Inc.
2010-06-21
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.