Identity
- Trade Name
- Care Touch FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Care Touch U-100 Insulin Syringes 31g 5/16"-8mm 1cc FDA UDI
- Model / Reference
- IS311 FDA UDI
- Description
- Care Touch U-100 Insulin Syringes 31g 5/16"-8mm 1cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00370393311015 FDA UDI
- 510(k) Number
- K152808 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
- Total Volume — .3 Milliliter FDA UDI
Category: Hypodermic needle, single-use
Care Touch by Future Diagnostics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Cleared under the same submission
K152808 also covers:
- EasyLife Insulin syringe 30G 1/2” 1cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife Insulin syringe 30G 5/16" 1cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife Insulin syringe 31G 5/16" 1cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 29G 1/2" 1ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 30G 1/2” 1/2ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 30G 1/2” 1ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 30G 5/16" 1/2ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 30G 5/16" 1ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 31G 5/16" 1/2ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 31G 5/16" 1ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- EasyLife safety Insulin syringe 32G 5/16" 1ml/cc 100pcs — CARE LIVING DIAGNOSTICS INC
- Care Touch — FUTURE DIAGNOSTICS LLC
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
- Future Diagnostics Llc
Sources (1)
- FDA UDI 65b74b52-2b2a-4be2-a71b-4e04b2e0feb9 36 fields · synced May 30, 2026