FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094190815
Brand
Bioseal Inc.
Company
BIOSEAL
Model
19081/24
Device description
Red Rubber Tubing
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094190812PackageGS124In Commercial Distribution
00630094190815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009419081210630094190812
00630094190815006300941908156300941908150630094190815

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815849025363Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.GAZ2026-10-06
00888867526174Arthrex®ARTHREX, INC.GAZ2026-09-29
10840113242761BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-21
10840113242815BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-21
10840113242754BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-18
10840113242778BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-18
00840113242764BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00840113242771BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00840113242818BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00810194403514AiraAIRA, LLCGAZ2026-08-26
00840329834494BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAZ2026-07-30
00840329836856BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAZ2026-07-30
10080196992805MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-22
10080196144310MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10884389123997MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10885380072352CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10080196035106MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035120MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035151MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035168MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035243MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035250MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
08809083944803EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944810EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944827EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944834EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28