AccessGUDID - DEVICE: N/A (04710810088148)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 38032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Hytrel hose15F cuff,L= 60 cm弓
Company Name: GALEMED CORPORATION

Primary DI Number: 04710810088148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656854379 *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:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Ventilator IMV supplemental circuit, reusable	A device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of durable materials and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9201f3b9-5244-4fa0-b3e3-ddac034b4a8b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 15, 2015