FDA.reportPublic FDA data

Diversatek Healthcare

Primary DI
M7831245280
Brand
Diversatek Healthcare
Company
DIVERSATEK HEALTHCARE, INC.
Model
1245-28
Catalog number
1245-28
Device description
Right Angle Thoracic Catheter, 28 French x 20 IN
Published
2018-09-07
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
GBSCatheter, Ventricular, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBSCatheter, Ventricular, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7831245281PackageHIBCC10In Commercial Distribution
M7831245280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pleural catheterA tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French
Length20Inch

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816734021286InnerVision®1465-401465-402018-09-18
00816734021293InnerVision®1465-501465-502018-09-18
00816734021217InnerVision®1450-021450-022018-09-18
00816734021224InnerVision®1450-401450-402018-09-18
00816734021231InnerVision®1450-501450-502018-09-18
00816734021248InnerVision®1450-561450-562018-09-18
00816734021255InnerVision®1455-401455-402018-09-18
00816734021262InnerVision®1455-501455-502018-09-18
00816734021279InnerVision®1455-561455-562018-09-18
00816734021309InnerVision®1465-561465-562018-09-18
00816734023518BullDog®1203-401203-402025-12-05
10816734023515BullDog®1203-401203-402025-12-05
M78312011160Diversatek Healthcare1201-1161201-1162025-11-14
00816734021682Diversatek HealthcareA86-1070A86-10702023-06-30
00816734021835Diversatek HealthcareA86-4300-10A86-4300-102023-06-30
00816734021859Diversatek HealthcareA86-5070A86-50702023-06-30
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011648116Automatic Continuous Effusion System (ACES) KitPleural Dynamics, Inc.GBS2026-07-13
00860011648109Automatic Continuous Effusion Shunt (ACES) SystemPleural Dynamics, Inc.GBS2026-05-21
00736239051000Novo VivoGenesis Industries, IncorporatedGBS2023-09-12
14710961935961Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935978Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935985Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935992Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936005Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936012Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936029Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936036Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936043Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936050Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936067Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936074Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936081Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936098Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936104Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936128Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936135Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936142Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936159Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936166Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936173Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936180Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936197Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936203Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936210Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936227Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936234Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15