Question 1

What types of medical devices does J&A Digital Inc. manufacture?

Accepted Answer

J&A Digital Inc. specializes in medicated first aid kits. These kits are designed for emergency preparedness and minor wound care, containing pre-packaged medical supplies like antiseptics, bandages, and pain relief medications. They are intended for use in non-clinical settings to address common injuries and health needs.

Question 2

Where is J&A Digital Inc. based?

Accepted Answer

J&A Digital Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional details are not provided.

Question 3

How are J&A Digital Inc.’s devices classified by the FDA?

Accepted Answer

J&A Digital Inc.’s medicated first aid kits fall under FDA Class N, which is a non-classified category. This classification means the devices are not assigned to a traditional risk-based class (I, II, or III) but are still subject to regulatory oversight through other mechanisms, such as the FDA’s Unique Device Identifier (UDI) database.

Question 4

Are J&A Digital Inc.’s devices listed in any regulatory registries?

Accepted Answer

Yes, J&A Digital Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through standardized identifiers, ensuring transparency and traceability in the supply chain.

Device	Model / Reference	Registries	Class	Status
KeepGoing First Aid	GoKit-Dino	FDA UDI	N	Active
KeepGoing First Aid	KG-Refill	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-HunterGreen	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-BOHO	FDA UDI	N	Active
KeepGoing First Aid	GoKit-FirstAid	FDA UDI	N	Active
KeepGoing First Aid	GoKit-Camping	FDA UDI	N	Active
KeepGoing First Aid	GoKit-Flamingo	FDA UDI	N	Active
KeepGoing First Aid	GoKit-PinkDino	FDA UDI	N	Active
KeepGoing First Aid	GoKit-WildSide	FDA UDI	N	Active
KeepGoing First Aid	GoKit-TieDye	FDA UDI	N	Active
KeepGoing First Aid	GoKit-BlueCamo	FDA UDI	N	Active
KeepGoing First Aid	MiniKit-FirstAid	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-Sports	FDA UDI	N	Active
KeepGoing First Aid	GoKit-HunterGreen	FDA UDI	N	Active
KeepGoing First Aid	MiniKit-HunterGreen	FDA UDI	N	Active
KeepGoing First Aid	GoKit-WhiteStripe	FDA UDI	N	Active
KeepGoing First Aid	GoKit-Sports	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-Woodland	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-Rainbow	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-Signature	FDA UDI	N	Active
KeepGoing First Aid	MiniKit-Signature	FDA UDI	N	Active
KeepGoing First Aid	SuperKit-FirstAid	FDA UDI	N	Active
KeepGoing First Aid	GoKit-Rainbow	FDA UDI	N	Active
KeepGoing First Aid	GoKit-STEM	FDA UDI	N	Active
KeepGoing First Aid	GoKit-BlueDot	FDA UDI	N	Active
KeepGoing First Aid	MiniKit-Woodland	FDA UDI	N	Active
KeepGoing First Aid	GoKit-Signature	FDA UDI	N	Active
KeepGoing First Aid	GoKit-Woodland	FDA UDI	N	Active
KeepGoing First Aid	MiniKit-Rainbow	FDA UDI	N	Active

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