AccessGUDID - DEVICE: Latex-free Breathing Bag

GUDID

Device Identifier (DI) Information

Brand Name: Latex-free Breathing Bag - 2 Liter
Version or Model: VM2LBB20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VM2LBB20
Company Name: Global Life Sciences Solutions USA LLC

Primary DI Number: 00636207315410
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011658242 *Terms of Use

Device Description: Latex-free Breathing Bag - 2 Liter

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?
34877	Breathing circuit bag, single-use	A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, bacterial, breathing-circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013093	000

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
Total Volume: 2 Liter

Device Record Status

Public Device Record Key: e8248cfe-5ec3-4a23-8515-845eeb4c186f
Public Version Date: February 29, 2024
Public Version Number: 4
DI Record Publish Date: June 29, 2016