DEVICE: Neonate Cuff (00847946026813)

Device Identifier (DI) Information

Neonate Cuff
1009-001643
In Commercial Distribution

Zoll Medical Corporation
00847946026813
GS1

1
055363428 *Terms of Use
ASSY, CUFF, NEONATE #4, LIMB CIRCUMFERENCE 7.0 CM TO 13.0 CM, DISPOSABLE (BOX OF 20)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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?
37326 Blood pressure cuff, single-use
A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXQ blood pressure cuff
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120125 000
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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 Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Handling Environment Temperature: exactly 0 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1e120fb9-9799-43b2-8d46-d52d787e7843
November 17, 2023
1
November 09, 2023
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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
No Package DIs found
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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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