AccessGUDID - DEVICE: SmartSite (10885403250859)

GUDID

Device Identifier (DI) Information

Brand Name: SmartSite
Version or Model: MV0450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MV0450
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403250859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: Syringe-Syringe Transfer Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41222	Medication transfer set	A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size = Priming Volume = 0.2 millilitre (mL)
Length: 5 Centimeter

Device Record Status

Public Device Record Key: 79385023-3e56-4673-91f9-9945c7bc4a00
Public Version Date: August 01, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50885403250857	2	20885403250856		In Commercial Distribution	Case
20885403250856	50	10885403250859		In Commercial Distribution	Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(844)823-5433
Email: customer_support@bd.com

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