FDA.reportPublic FDA data

Bolin Chest Seal

Primary DI
00857048006286
Brand
Bolin Chest Seal
Company
H&H MEDICAL CORPORATION
Model
6
Catalog number
BCS01
Device description
Bolin Chest Seal valved chest dressing used for sealing open chest wounds and reducing the risk of tension pneumothoraxl
Published
2020-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857048006286PackageGS110In Commercial Distribution
00857048006293PackageGS125In Commercial Distribution
00857048006132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857048006286008570480062868570480062860857048006286
00857048006293008570480062938570480062930857048006293
00857048006132008570480061328570480061320857048006132

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax dressingA sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
804-642-3663info@gohandh.com

Regulatory Flags#

DUNS number
072656713
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857048006064H&H Big Cinch Abdominal Bandage1BC012020-07-10
00857048006095H-Bandage Compression Dressing, Flat Fols1HBFF012020-07-10
00857048006101Thin H Compression Bandage, Standard Fold1HBT012020-07-10
00857048006118Thin H Compression Dressing, Flat Fold1HBTF2020-07-10
00857048006125Mini Compression Bandage1HHMCB012020-07-10
00857048006057H&H Situation Instrument Tray Kit1HHSIT012020-07-06
00857048006392SWAT-T Elastic Tourniquet, Black1SWAT-T-BLK-EA2020-12-31
00857048006422SWAT-T Elastic Tourniquet, Orange1SWAT-T-BLK-EA2020-12-31
00857048006316TK-4 Elastic Tourniquet1TK-42020-12-31
00857048006323TK-4L Elastic Tourniquet1TK-4L2020-12-31
00857048006484H&H Combat Medic Tape1CMRT012020-12-31
00857048006361H&H Compressed Gauze1HHPG2020-12-31
00857048006521H&H Flat Compressed Gauze1HHPF2020-12-31
00857048006538H&H TACgauze Wound Wrapping Gauze1TACG022020-12-31
00857048006545H&H MiniTAC Wound Wrapping Gauze1HHMTG012020-12-31
00857048006088H-Bandage Compression Dressing - Rolled1HB012020-07-10
00857048006583H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006590H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006132Bolin Chest Seal6BCS012020-12-31
00857048006552H&H 30fr Nasopharyngeal Airway, Each1.0HHNPA-EA2020-12-31

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