DEVICE: Atmos (08032248487130)

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Device Record History
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Device Identifier (DI) Information
Atmos
UD-A36205
In Commercial Distribution

DELTA MED SPA
08032248487130
GS1

1
444776777 *Terms of Use
E261UDA362050
Pump Tubing 3,2 x 6,4
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
14301 Urological irrigation set
A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EXQ Cystometer, Electrical Recording
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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
Handling Environment Temperature: between 5 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 6.4 Millimeter
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Device Record Status
505c13a0-cd11-4abc-9bd9-e0755cbf1b99
September 10, 2025
1
September 02, 2025
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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
38032248487131 25 08032248487130 In Commercial Distribution shelf box
58032248487135 2 38032248487131 In Commercial Distribution Shipping 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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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