UDI device identifier

Giraffe Stand-alone Infant Resuscitation System Bag and Mask

UDI device identifier 00840682100175 · Datex-Ohmeda, Inc.

Key facts

Primary DI 00840682100175
Brand name Giraffe Stand-alone Infant Resuscitation System
Version or model Bag and Mask
Company Datex-Ohmeda, Inc.
DUNS number 118933716
Product code BTM
GMDN term Pulmonary resuscitator, pneumatic, reusable
Premarket submission K070247
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Sep 23, 2015
Version date Apr 3, 2025
Description GIRAFFE STAND-ALONE INFANT RESUSCITATION SYSTEM BAG AND MASK

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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