DEVICE: RespVac™ (00850108006431)

Device Identifier (DI) Information

RespVac™
RTG-02416
In Commercial Distribution
RTG-02416
CUTTING EDGE HC BRANDS LLC
00850108006431
GS1

1
080216804 *Terms of Use
RespVac Suction Catheter Kit Sterile 16FR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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?
13846 Secretion suction kit
A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
BSY Catheters, Suction, Tracheobronchial
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FDA Premarket Submission

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

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Avoid freezing and exessive heat.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 16 French
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Device Record Status

9cb503cf-dba2-4bea-a342-d16a9060f99f
January 09, 2023
1
December 30, 2022
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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
10850108006438 100 00850108006431 In Commercial Distribution Carton
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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

[?]
9999999999
info@respiratorytg.com
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