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Pediatric EDGE System RTS Electrodes with QUIK-COMBO Connector

FDA UDI

Class III (US FDA UDI)

by PHYSIO-CONTROL, Inc.

Identity

Trade Name
Pediatric EDGE System RTS Electrodes with QUIK-COMBO Connector FDA UDI
Generic Name
External defibrillation electrode, adult, single-use FDA UDI
Device Name
ELECT ASSY-PED RTS,WORLDWIDE,3RD EDITION FDA UDI
Model / Reference
11996 FDA UDI
Description
ELECT ASSY-PED RTS,WORLDWIDE,3RD EDITION FDA UDI

Identifiers

Catalog Number
11996-000093 FDA UDI
Primary DI / UDI-DI
00721902207501 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
External defibrillation electrode, adult, single-use FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 FDA UDI
Commercial Distribution
Not 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

No

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
MRI Safety
MR Unsafe FDA UDI

Pediatric EDGE System RTS Electrodes with QUIK-COMBO Connector by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PHYSIO-CONTROL, Inc.

Sources (1)

  • FDA UDI b4b7ae5d-c045-4d93-b3ea-81ca70b34094 36 fields · synced Jun 9, 2026