FDA.reportPublic FDA data

Bosma Enterprises

Primary DI
00818634020758
Brand
Bosma Enterprises
Company
Bosma Enterprises
Model
10-8020LRC
Catalog number
10-8020LRC
Device description
"Accelerate-OR Cath & EP LRC Kit; Each Kit Includes QuickSuite Kit, 60x78 Patient Lift Sheet, 40x60 Sahara OR Table Sheet 20"" Absorb, and Armboard Covers with Integrated Straps."
Published
2021-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWUClean-Up Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWUClean-Up KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818634020755PackageGS112In Commercial Distribution
00818634020758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081863402075510818634020755
00818634020758008186340207588186340207580818634020758

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer/turning sheetA manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat. Keep dry.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-362-5463kimm@bosma.org
800-362-5463quality@bosma.org

Regulatory Flags#

DUNS number
878070325
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818634025606C.R. Bard10-01011210-0101122026-05-14
10818634025613C.R. Bard10-01011410-0101142026-05-14
10818634025620C.R. Bard10-01011610-0101162026-05-14
10818634025637C.R. Bard10-01011810-0101182026-05-14
10818634025644C.R. Bard10-01012010-0101202026-05-14
10818634025651C.R. Bard10-12061010-1206102026-05-14
10818634025668C.R. Bard10-12061210-1206122026-05-14
10818634025675C.R. Bard10-12061410-1206142026-05-14
10818634025682C.R. Bard10-12061610-1206162026-05-14
10818634025699C.R. Bard10-12061810-1206182026-05-14
10818634025705C.R. Bard10-12062010-1206202026-05-14
00818634020635Bosma Enterprises10-8020PAO10-8020PAO2026-05-14
00818634025210Bosma Enterprises10-9030WIL10-9030WIL2026-05-14
00818634025838Bosma Enterprises10-9030WI210-9030WI22026-05-14
00818634026040Bosma Enterprises10-8020SAL210-8020SAL22026-05-14
10818634021387Gammex71-851171-85112021-07-01
10818634021394Gammex71-851271-85122021-07-01
10818634021400Gammex71-851371-85132021-07-01
10818634021417Gammex71-851471-85142021-07-01
10818634021424Gammex71-851571-85152021-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818634020635Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025210Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025838Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634026040Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025807Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634025821Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634025890Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026019Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026026Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026033Bosma EnterprisesBosma EnterprisesPWU2026-04-14
10197106978825CARDINAL HEALTHCardinal Health 200, LLCPWU2025-10-03
10198956020054CARDINAL HEALTHCardinal Health 200, LLCPWU2025-03-14
50198956020052CARDINAL HEALTHCardinal Health 200, LLCPWU2025-03-14
10197106754795CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
50197106754793CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
00818634025531Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025586Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025593Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025524Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025538Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025583Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025590Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10304040167974Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
00304040167977Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
10197106289914CARDINAL HEALTHCardinal Health 200, LLCPWU2023-06-15
50197106289912CARDINAL HEALTHCardinal Health 200, LLCPWU2023-06-15
M75257014920STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-04-05
M75257027820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-03-10
10195594555733CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03
50195594555731CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03