← Back to catalogue

Inject-Ease

FDA UDI

Class II (US FDA UDI)

by Ambi, Inc.

Identity

Trade Name
Inject-Ease FDA UDI
Generic Name
Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Device Name
Holder for disposable syringes that hides the needle and makes self-injections easier FDA UDI
Model / Reference
IE400 FDA UDI
Description
Holder for disposable syringes that hides the needle and makes self-injections easier FDA UDI

Identifiers

Catalog Number
IE400 FDA UDI
Primary DI / UDI-DI
00025294874007 FDA UDI
510(k) Number
K872233 FDA UDI
FDA Product Code
KZH FDA UDI
GMDN Term
Syringe-loaded medication/vaccine injector, manual, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 5.4 Inch FDA UDI
Width — 1.7 Inch FDA UDI

Category: Syringe-loaded medication/vaccine injector, manual, professional

Inject-Ease by Ambi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Syringe-loaded medication/vaccine injector, manual, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ambi, Inc.

Sources (1)

  • FDA UDI 040a0e25-6411-4b14-94ed-c7f086937954 37 fields · synced Jun 8, 2026