AccessGUDID - DEVICE: Y-Piece (00627825008204)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Piece
Version or Model: 9021P1164
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Laborie Medical Technologies Canada ULC

Primary DI Number: 00627825008204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203383526 *Terms of Use

Device Description: No description.

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):	No
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?
36244	Electronic gravity infusion controller administration set	A collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEN	DEVICE, CYSTOMETRIC, HYDRAULIC

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a8f699d-e172-4317-b5ae-8d69162601b1
Public Version Date: October 10, 2022
Public Version Number: 3
DI Record Publish Date: September 21, 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
10627825008201	10	00627825008204		In Commercial Distribution

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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