AccessGUDID - DEVICE: Mabis (00767056181212)

GUDID

Device Identifier (DI) Information

Brand Name: Mabis
Version or Model: 40-742-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 00767056181212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: Steam Inhaler w/Facial Mask

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:	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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63562	Home-use facial steamer	An electrically-powered device designed to create steam for facial skin cleansing, typically by providing a cone-shaped applicator for channelling the steam to the face. It may also be used for clearing the nasal passages by inhalation of the steam. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)

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: dfc1f5e6-4376-44ee-8edf-55285ccb4035
Public Version Date: January 11, 2024
Public Version Number: 1
DI Record Publish Date: January 03, 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
10767056181219	6	00767056181212		In Commercial Distribution	Master carton

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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