AccessGUDID - DEVICE: Passy-Muir (10859760005131)

GUDID

Device Identifier (DI) Information

Brand Name: Passy-Muir
Version or Model: PMV-AD22
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMV-AD22
Company Name: PASSY-MUIR, INC.

Primary DI Number: 10859760005131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 174508630 *Terms of Use

Device Description: PMV® 22mm Silicone Adapter

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":	No
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?
63623	Tracheostoma device adaptor, reusable	A noninvasive device intended to be used use in the home and clinical settings by a person breathing through a tracheostoma to facilitate the connection of a device at the tracheostoma, on the skin side [e.g., hands-free speech valve, heat and moisture exchanger (HME)]. It is typically made of synthetic polymer materials and in the form of a connecting ring of various mating diameters. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	Connector, Airway (Extension)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 088758c5-df69-49bd-a754-5375742fab44
Public Version Date: December 23, 2024
Public Version Number: 2
DI Record Publish Date: August 03, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00859760005134 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9498338255
Email: info@passymuir.com

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