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
Resuscitator with Reservoir Bag
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Device Characteristics

MR Conditional
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36690 Cardiopulmonary resuscitation kit, reusable
A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OEV Cardiopulmonary resuscitation aid kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -18 and 50 Degrees Celsius
Storage Environment Temperature: between -18 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Baby
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Device Record Status

df085ee4-1fed-413d-9c07-0380656906dd
September 17, 2024
3
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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