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ambIT

FDA UDI

Class II (US FDA UDI)

by Summit Medical Products, Inc.

Identity

Trade Name
ambIT FDA UDI
Generic Name
Electric infusion pump administration set, single-use FDA UDI
Device Name
PIB/PCA v1.5 Pain Control System-Basic FDA UDI
Model / Reference
220573 FDA UDI
Description
PIB/PCA v1.5 Pain Control System-Basic FDA UDI

Identifiers

Catalog Number
220573 FDA UDI
Primary DI / UDI-DI
00850000509047 FDA UDI
FDA Product Code
OFQ FDA UDI
GMDN Term
Electric infusion pump administration set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electric infusion pump administration set, single-use

ambIT by Summit Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electric infusion pump administration set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Medical Products, Inc.

Sources (1)

  • FDA UDI cef00f1e-e787-4cf5-8629-d5f5398d067c 35 fields · synced Jun 6, 2026