AccessGUDID - DEVICE: Alaris (10885403274008)

GUDID

Device Identifier (DI) Information

Brand Name: Alaris
Version or Model: 30863
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30863
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403274008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: PCA Administration Set, Microbore Tubing Anti-siphon Valve 160 cm (63 in)

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?
41477	Patient-controlled analgesia electric infusion pump administration set	A collection of sterile devices that typically consists of a reservoir (e.g., a syringe or plastic pouch), plastic tubing, a check valve, and Luer connectors, designed for the controlled intravenous (IV) administration of opioid pain medication using an electrically-powered, patient-controlled analgesia (PCA) infusion pump. 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
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 63 Inch

Device Record Status

Public Device Record Key: 079876b4-8ce8-429d-9991-33b12db3f0aa
Public Version Date: March 06, 2024
Public Version Number: 5
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
50885403274006	50	10885403274008		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(844)823-5433
Email: customer_support@bd.com

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