FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094175253
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17525/12
Device description
Griffin Beaker Capacity 250mL
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYWCONTAINER, LIQUID MEDICATION, GRADUATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094175253PackageGS112In Commercial Distribution
00630094175256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417525310630094175253
00630094175256006300941752566300941752560630094175256

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, single-useA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630094489025Bioseal Inc.DURA902/1002025-05-29
00630094480503Bioseal Inc.DURA050/1002025-05-28
10630094292240Bioseal Inc.32-922-4/202024-01-10
10630094335404Bioseal Inc.33-540/202024-01-10
10630094055111Bioseal Inc.551S/202024-01-29
10630094055135Bioseal Inc.551L/202024-01-29
10630094055142Bioseal Inc.551M/202024-01-29
10630094055197Bioseal Inc.551R/202024-01-29
10630094061501Bioseal Inc.6150/252024-01-29
10630094061518Bioseal Inc.6151/252024-01-29
10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80827989007907Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007914Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007921Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
30815112021444Mixing ContainerBracco Diagnostics Inc.KYW2026-01-09
00194613039127MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613046330MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613096502MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613121082MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
06931918145061AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
10661392002187LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
10661392012339LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00194613096519MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-03-21
00194613122669MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-03-21
10827989000268Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-03-13
10827989003627Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-03-13
20827989003464Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003471Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003488Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003495Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
00840306835964Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-12-11
00810180844918Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00840117341210Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00840306835926Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306835957Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306835971Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306835995Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306836015Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00653160381467MEDLINEMEDLINE INDUSTRIES, INC.KYW2024-10-18
00840216128033ASP MEDICALAsp Global, LLCKYW2024-09-12