DEVICE: Mark IV Baby Resuscitator (05707480035250)

Device Identifier (DI) Information

Mark IV Baby Resuscitator
299007000
In Commercial Distribution
299007000
Ambu A/S
05707480035250
GS1

1
305682023 *Terms of Use
Ambu Mark IV Bab with closed oxygen reservoir, Silicone face mask size 0 with blue cuff.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
Yes
No
No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17591 Pulmonary resuscitator, manual, reusable
A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
BTM Ventilator, emergency, manual (resuscitator)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -18 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Baby
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Device Record Status

df085ee4-1fed-413d-9c07-0380656906dd
March 29, 2018
2
December 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480019571 12 05707480035250 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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