DEVICE: Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask (00084424900574)

Device Identifier (DI) Information

Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
1055-E
In Commercial Distribution
1055-E
UNOMEDICAL, INC.
00084424900574
GS1

1
030271837 *Terms of Use
Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Resuscitator face mask, single-use A non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. 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
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e83f55a7-024a-439f-bb2d-8a8771449a17
March 29, 2018
2
October 15, 2015
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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
20844249005747 20 00084424900574 In Commercial Distribution case
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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
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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