DEVICE: SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator (05707480033300)

Device Identifier (DI) Information

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator
530213000
In Commercial Distribution
530213000
Ambu A/S
05707480033300
GS1

1
305682023 *Terms of Use
Ambu SPUR II Pediatric with closed reservoir, wtih Duraclear face mask size toddler/pediatric 12 pcs/box
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Pulmonary resuscitator, manual, single-use A non-sterile, 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 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 single-use device.
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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

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 60 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: Pediatric
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Device Record Status

3640eaf8-0ed5-482e-b202-a8c84242f946
March 29, 2018
2
December 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480017515 12 05707480033300 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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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