AccessGUDID - DEVICE: SmartSite (10885403234163)

GUDID

Device Identifier (DI) Information

Brand Name: SmartSite
Version or Model: 10237425
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10237425
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403234163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: 4-Way Stopcock Needle-Free Valve Needle-Free Valve to Male Luer

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?
32172	Intravenous line stopcock	A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMG	Stopcock, i.V. Set

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
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1acd1a9a-2223-4307-8651-e1004a4975fc
Public Version Date: August 20, 2024
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
50885403234161	100	10885403234163		In Commercial Distribution	Case
20885403234160	50	10885403234163		In Commercial Distribution	Shelfpack

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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