AccessGUDID - DEVICE: Life Support Products (00260720000364)

GUDID

Device Identifier (DI) Information

Brand Name: Life Support Products
Version or Model: L034-100R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L034-100R
Company Name: ALLIED HEALTHCARE PRODUCTS, INC.

Primary DI Number: 00260720000364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099674145 *Terms of Use

Device Description: Elder Valve, w/Restr

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:	No
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Demand valve	A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
BTL	Ventilator, Emergency, Powered (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915564	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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00d50b7b-a2ba-4894-9a4a-4b7869d2e867
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 20, 2015