DEVICE: Alaris, SmartSite (10885403238048)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Alaris, SmartSite
22401-0007
In Commercial Distribution
22401-0007
BD Switzerland Sàrl
10885403238048
GS1

1
482631558 *Terms of Use
Pump Infusion Burette Set 0.2 Micron Filter, Port (Burette) Ball Valve, 313 cm (123 in)
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 123 Inch
CLOSE

Device Record Status
a5b3ebfc-d52a-42df-aafe-9d1646417ad8
August 14, 2024
5
October 17, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50885403238046 10 10885403238048 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(844)823-5433
customer_support@bd.com
CLOSE