FDA.reportPublic FDA data

SWIK Modular Extension Tubing

Primary DI
00860349001737
Brand
SWIK Modular Extension Tubing
Company
Saliva Management Systems, Inc.
Model
SWK-T56
Catalog number
SWK-T56
Device description
Extension Tubing, with pump connector, for SWK-M16 oral secretion management device. (Used with SWK-M16 modular mouthpiece)
Published
2025-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, Saliva Ejector
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860349001737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860349001737008603490017378603490017370860349001737

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119148960
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860349001720SWIK Modular MouthpieceSWK-M16SWK-M162025-06-17
00860349001713SWIKSWK-2002024-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955IRRTIP1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKO1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOT1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOTS1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOWT1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
00810194403187AiraAIRA, LLCEHZ2026-08-26
00810194403231AiraAIRA, LLCEHZ2026-08-26
00810194403248AiraAIRA, LLCEHZ2026-08-26
00810194404023AiraAIRA, LLCDYN2026-08-26
00810194404122AiraAIRA, LLCDYN2026-08-26
00810194404146AiraAIRA, LLCDYN2026-08-26
00810194404160AiraAIRA, LLCDYN2026-08-26
00810194404184AiraAIRA, LLCDYN2026-08-26
00814005020006TAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502001315P2-90AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502003703BATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502005115P3AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502006803BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502008202BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502009946P3MQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502010515P2ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502013615P2AQUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020143FR3QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020174FR15P2QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020181FR2QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020198FR4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502020446P3ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502021115P2-1/4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502022815P3-1/4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502023556P2QUALITY ASPIRATORS, INC.EHZ2025-02-27