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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
Ambulatory non-insulin infusion pump, electronic FDA UDI
Device Name
PCA Military Pump FDA UDI
Model / Reference
220437 FDA UDI
Description
PCA Military Pump FDA UDI

Identifiers

Catalog Number
220437 FDA UDI
Primary DI / UDI-DI
00857595005671 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Ambulatory non-insulin infusion pump, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory non-insulin infusion pump, electronic

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

Similar devices

Also classified as Ambulatory non-insulin infusion pump, electronic.

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 7187b3d7-9d60-4821-85be-b1651ae27c1d 36 fields · synced May 30, 2026