Identity
- Trade Name
- Easy Comfort Syringes 31G 5/16" 0.3CC FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- Easy Comfort Syringes 31G 5/16" 0.3CC FDA UDI
- Model / Reference
- 4654 FDA UDI
- Description
- Easy Comfort Syringes 31G 5/16" 0.3CC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027494654 FDA UDI
- 510(k) Number
- K223453 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 31 Gauge FDA UDI
Category: Metered-delivery hypodermic syringe
Easy Comfort Syringes 31G 5/16" 0.3CC by Home Aide Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223453 also covers:
- Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Syringes 31G 1/2" 0.3CC — HOME AIDE DIAGNOSTICS, INC.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI a617629d-36d9-4002-a9b6-b0afbc12b045 36 fields · synced May 30, 2026