AccessGUDID - DEVICE: DeVilbiss (00885304032557)

GUDID

Device Identifier (DI) Information

Brand Name: DeVilbiss
Version or Model: 7325D-D-EXF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7325D-D-EXF
Company Name: DEVILBISS HEALTHCARE LLC

Primary DI Number: 00885304032557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962175894 *Terms of Use

Device Description: Vacu-Aide Suction Machine

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":	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10749	Airway suction catheter	A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982304	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
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 77 and 106 KiloPascal
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -13 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a588dbe-885a-48f4-9c46-f6df4e7a9b80
Public Version Date: November 18, 2024
Public Version Number: 1
DI Record Publish Date: November 08, 2024

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: No Unit of Use DI Numbers Found 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-338-1988
Email: somdhccustomerservice@devilbisshc.com

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