AccessGUDID - DEVICE: ALL-IN-ONE (00085412041414)

GUDID

Device Identifier (DI) Information

Brand Name: ALL-IN-ONE
Version or Model: 2B8134
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2B8134
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412041414
Issuing Agency: GS1
Commercial Distribution End Date: September 14, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 3000 mL Capacity

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?
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPE	CONTAINER, I.V.

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: d6d2b3da-088f-4247-aa53-acb3bc66f36b
Public Version Date: July 07, 2023
Public Version Number: 8
DI Record Publish Date: September 24, 2016