AccessGUDID - DEVICE: Alaris (10885403221705)

GUDID

Device Identifier (DI) Information

Brand Name: Alaris
Version or Model: 10012241-0500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10012241-0500
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403221705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: Closed 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?
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system

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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Storage Temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size = Priming Volume = 0.12 millilitre (mL)

Device Record Status

Public Device Record Key: 80b4ff5b-5a98-42d2-a3d1-f541495f589d
Public Version Date: August 01, 2025
Public Version Number: 8
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
20885403221702	50	10885403221705		In Commercial Distribution	Box
50885403221703	2	20885403221702		In Commercial Distribution	Case

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(800)854-7128
Email: CustCareInfusion@carefusion.com

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

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