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Oral Tamper Evident Cap

FDA UDI

Class I (US FDA UDI)

by International Medical Industries Inc.

Identity

Trade Name
Oral Tamper Evident Cap FDA UDI
Generic Name
Non-ISO80369-3-standardized oral syringe FDA UDI
Device Name
RFID OTEC – 100 units/bag, 1 bag/carton FDA UDI
Model / Reference
57-70-100 RFID FDA UDI
Description
RFID OTEC – 100 units/bag, 1 bag/carton FDA UDI

Identifiers

Catalog Number
57-70-100 RFID FDA UDI
Primary DI / UDI-DI
B2125770100RFID1 FDA UDI
FDA Product Code
KYX FDA UDI
GMDN Term
Non-ISO80369-3-standardized oral syringe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6430 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Non-ISO80369-3-standardized oral syringe

Oral Tamper Evident Cap by International Medical Industries Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-ISO80369-3-standardized oral syringe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
International Medical Industries Inc.

Sources (1)

  • FDA UDI cb9d7ec5-60e3-4f75-b416-5c48c166c2e1 34 fields · synced Jun 8, 2026