DEVICE: Technical Products (B0516021050)

Device Identifier (DI) Information

Technical Products
602-105
In Commercial Distribution

TECHNICAL PRODUCTS INC
B0516021050
HIBCC

1
040679649 *Terms of Use
silicone Tubing
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Device Characteristics

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

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
Gas dehumidification tubing set, single-use A collection of devices intended to be used for the purpose of dehumidifying exhaled gas prior to its analysis in a gas analyser. It is composed of a length of hollow tubing made from one of several malleable or semi-rigid materials (e.g., silicone, plastic, rubber or nylon) and an integrated filter which absorbs (subtracts) the humidity from the gases before they enter the analysing chamber of the parent device. It has a limited lifetime and may be exchanged by the user, in which case it will typically be located on the outside of the parent device. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MIB Elastomer, Silicone Block
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K971613 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
Lumen/Inner Diameter: .012 Inch
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Device Record Status

1e3b2bcb-2533-49bf-8f71-b5001a902b9a
July 06, 2018
3
September 30, 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
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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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