Identity
- Trade Name
- First Aid Kit EUDAMEDOuterbanks FDA UDI
- Generic Name
- First aid kit, non-medicated, single-use FDA UDI
- Device Name
- First Aid Kit EUDAMEDFS-9020 First Aid Kit FDA UDI
- Model / Reference
- FS-9020 EUDAMEDFDA UDI
- Description
- FS-9020 First Aid Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942272609205 EUDAMEDB448FS90200 FDA UDI
- Basic UDI-DI
- 69422726J1.01.54SV EUDAMED
- FDA Product Code
- OHO FDA UDI
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
- GMDN Term
- First aid kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Medical Purpose
- First Aid Guide； Safety Pins； CPR Face Shield； Cleansing Wipes； Triangle Bandage； Plaster Dressing 7.2 × 1.9cm； Plaster Dressing 7.5 × 2.5cm； Scissors； Adhesive Tape 1.25 x 450cm； Gauze Pad 3" x 3 "； PVC Gloves； Elastic Bandage； Plastic Tweezers； Lancets； First Aid Bag EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
First Aid Kit by Firstar Healthcare Company Limited (guangzhou) — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69422726J1.01.54SV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Firstar Healthcare Company Limited (guangzhou)
- EUDAMED SRN
- CN-PR-000037943
Sources (2)
- EUDAMED 438e92be-e12a-44c2-8d26-4fdc1136eb18 61 fields · synced Oct 6, 2026
- FDA UDI 4695981c-69b7-42e0-a0e0-4803e0e0a72b 33 fields · synced May 30, 2026