FDA.reportPublic FDA data

Bosma Enterprises

Primary DI
10818634020847
Brand
Bosma Enterprises
Company
Bosma Enterprises
Model
10-9030PTH
Catalog number
10-9030PTH
Device description
Patient Transportation PTH Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 40x80 XL Lift Sheet, and STAT-BLOC Disposable Pillowcase.
Published
2021-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10818634020847PackageGS120In Commercial Distribution
00818634020840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081863402084710818634020847
00818634020840008186340208408186340208400818634020840

GMDN Terms#

Term, Definition table
TermDefinition
Pillow cover, single-useA device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. 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

Regulatory Flags#

DUNS number
878070325
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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