FDA.reportPublic FDA data

AFFLINK

Primary DI
00818634024879
Brand
AFFLINK
Company
Bosma Enterprises
Model
10-90702S
Catalog number
10-90702S
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
10818634024876PackageGS130Not in Commercial Distribution
00818634024879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081863402487610818634024876
00818634024879008186340248798186340248790818634024879

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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