AccessGUDID - DEVICE: NA (10620974001666)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: SMDIA-1200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMDIA-1200
Company Name: Southmedic Incorporated

Primary DI Number: 10620974001666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 246848147 *Terms of Use

Device Description: MDI Adaptor for use with or without dosage counters - 22 mm OD x 15 mm ID / 22 mm OD x 15 mm ID

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?
61166	Inhalation-therapy adaptor, single-use	A connecting device, usually with a small channel or tubing, intended to join a water/saline pack or a noninvasive ventilation respiratory unit to an inhalation therapy device (e.g., humidifier, vibrating mesh nebulizer, oxygen therapy delivery system). It may be used when the connection is compatible (e.g., when the connected devices are of the same manufacture) or when incompatible (e.g., different manufacture). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101953	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: MDI Adaptor for use with or without dosage counters - 22 mm OD x 15 mm ID / 22 mm OD x 15 mm ID

Device Record Status

Public Device Record Key: 46aef85b-f25b-444d-bd0c-5aab12a8e871
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 01, 2016