DEVICE: Medline (10889942820214)

Device Identifier (DI) Information

Medline
UROT1041
In Commercial Distribution
UROT1041
MEDLINE INDUSTRIES, INC.
10889942820214
GS1

1
025460908 *Terms of Use
TRAY CAUTI TEMP SENS 16FR 10ML
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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?
46629 Temperature-monitoring indwelling urethral drainage catheter
A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OHR Catheter care tray
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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
No storage/handling found
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Clinically Relevant Size

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

5418f29a-0637-4cad-9743-4bc248a03a4a
March 25, 2021
1
March 17, 2021
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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
40889942820215 10 10889942820214 In Commercial Distribution CASE
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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

[?]
+1(800)633-5463
service@medline.com
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