DEVICE: Alaris, SmartSite, Texium (10885403240959)

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Device Record History
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Device Identifier (DI) Information
Alaris, SmartSite, Texium
24601-B007T
In Commercial Distribution
24601-B007T
BD Switzerland Sàrl
10885403240959
GS1

1
482631558 *Terms of Use
Pump Infusion Set, Bag Access Non-Vented, Low Sorbing Tubing (PE Lined) Bonded Closed Male Luer with Priming Cap, Back Check Valve, 2 Y-Sites, 300 cm (118 in)
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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?
35833 Electric infusion pump administration set, single-use
A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
LHI Set, i.V. Fluid transfer
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Length: 300 Inch
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Device Record Status
8d55616a-cbbd-4857-bc9d-577bc1f68c69
March 06, 2024
5
September 22, 2016
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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
50885403240957 20 10885403240959 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(844)823-5433
customer_support@bd.com
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