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

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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

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