ADULT TIP SUCKER

Primary DI
B066201080NS1
Brand
ADULT TIP SUCKER
Company
NOVOSCI CORP.
Model
201080NS
Catalog number
201080NS
Device description
An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.
Published
2015-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTSSucker, Cardiotomy Return, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K801400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801400000DISPOSABLE SUCKER SYSTEMTexas Medical Products, Inc.1980-06-30DTS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B066201080NS3PackageHIBCC50In Commercial Distribution
B066201080NS1PrimaryHIBCC0
B066201080NS0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-854-0567info@novosci.com

Regulatory Flags#

DUNS number
938289980
Device count
100
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0662010110000STOPCOCK, TMP 3-WAY W/LUER LOCK201011-000201011-0002015-09-14
B0662010120000STOPCOCK, TMP 4-WAY W/LUER LOCK201012-000201012-0002015-09-14
B0663110330000TUBING ORGANIZER - STERILE311033-000311033-0002015-10-06
B066311033NS1TUBING ORGANIZER - NON-STERILE 311033NS311033NS2015-10-13
B0663110340000PEDIATRIC TUBING ORGANIZER - STERILE311034-000311034-0002015-10-12
B066311034NS1PEDIATRIC TUBING ORGANIZRER - NON-STERILE311034NS311034NS2015-10-13
B066321244NS1"CONNECTOR, 1/4"" X 1/2"" X 1/2"" CLEAR PAY "321244NS321244NS2015-10-13
B066201006NS1CANNULAE, SAPHENOUS VEIN201006NS201006NS2015-11-11
B066301011NS1"QUICKIE PRIME - 1/4"" x 1/16"""301011NS301011NS2017-12-06
B066331011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE "331011NS331011NS2015-10-13
B066331012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE"331012NS331012NS2015-10-13
B066331022NS1"CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE"331022NS331022NS2015-10-13
B066331023NS1"CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE"331023NS331023NS2015-10-13
B066331024NS1"CONNECTOR, 1/4"" X 1/2"" W/OUT LUER "331024NS331024NS2015-10-13
B066331033NS1"CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE"331033NS331033NS2015-10-13
B066331034NS1"CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE"331034NS331034NS2015-10-13
B066331044NS1"CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE"331044NS331044NS2015-10-13
B066332011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE W/LUER"332011NS332011NS2015-10-13
B066332012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER"332012NS332012NS2015-10-13
B066332022NS1"CONNECTOR, 1/4"" X 1/4"" W/LUER"332022NS332022NS2015-10-13

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Primary DI, Brand, Company table
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