Identity
- Trade Name
- EZ FLO FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- HYPODERMIC NEEDLE 18G X 1-1/2" FDA UDI
- Model / Reference
- NEZ18112 FDA UDI
- Description
- HYPODERMIC NEEDLE 18G X 1-1/2" FDA UDI
Identifiers
- Catalog Number
- NEZ18112 FDA UDI
- Primary DI / UDI-DI
- 10850017403052 FDA UDI
- 510(k) Number
- K112057 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hypodermic needle, single-use
Ez Flo by Air-Tite Products Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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- 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
K112057 also covers:
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
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 |
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Manufacturer
- Manufacturer
- Air-Tite Products Company, Inc.
Sources (1)
- FDA UDI da5f39d4-49cf-493f-a57a-a1f17f3d97e4 36 fields · synced Jun 7, 2026