AccessGUDID - DEVICE: AG Cuffill (cmH2O) (07290015409001)

GUDID

Device Identifier (DI) Information

Brand Name: AG Cuffill (cmH2O)
Version or Model: HSCUFF0041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HSCUFF0041
Company Name: HOSPITECH RESPIRATION LTD

Primary DI Number: 07290015409001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514824387 *Terms of Use

Device Description: The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35401	Endotracheal tube cuff inflator	A manually-powered device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSK	Cuff, Tracheal Tube, Inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122721	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
Storage Environment Temperature: between -32 and 104 Degrees Fahrenheit
Handling Environment Temperature: between -32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0bcbf51d-bb17-4af1-8e3e-b457e2e24ab1
Public Version Date: March 21, 2019
Public Version Number: 5
DI Record Publish Date: September 16, 2016