FDA.reportPublic FDA data

Bosma Enterprises

Primary DI
00818634024831
Brand
Bosma Enterprises
Company
Bosma Enterprises
Model
10-90701S
Catalog number
10-90701S
Device description
Wounded Warrior PPE Kit-Small; Each Kit Includes Small Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Published
2021-07-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXCPersonal Protection Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXCPersonal Protection KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818634024838PackageGS130Not in Commercial Distribution
00818634024831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081863402483810818634024838
00818634024831008186340248318186340248310818634024831

GMDN Terms#

Term, Definition table
TermDefinition
Skin cleaning wipeA device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
800-362-5463kimm@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
00842209136025NARNORTH AMERICAN RESCUE, LLCPXC2025-08-25
10194717120070Regard™ROI CPS, LLCPXC2024-10-02
10194717120131Regard™ROI CPS, LLCPXC2024-10-02
20194717120077Regard™ROI CPS, LLCPXC2024-10-02
20194717120138Regard™ROI CPS, LLCPXC2024-10-02
10194717119913Regard™ROI CPS, LLCPXC2024-08-14
20194717119910Regard™ROI CPS, LLCPXC2024-08-14
10194717119746Regard™ROI CPS, LLCPXC2024-06-20
20194717119743Regard™ROI CPS, LLCPXC2024-06-20
00842209130665NARNORTH AMERICAN RESCUE, LLCPXC2024-04-29
10194717116042Regard™ROI CPS, LLCPXC2022-07-11
20194717116049Regard™ROI CPS, LLCPXC2022-07-11
M7526892650STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-21
M7526871050STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-17
M7526894290STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-14
M7526891530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-02
00612479259102McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259126McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259119McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259133McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00816703025727MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403338MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403369MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00816703025734MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403345MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403376MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00816703028544MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028568MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028582MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028605MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22