AccessGUDID - DEVICE: Ohio (00628101612863)

GUDID

Device Identifier (DI) Information

Brand Name: Ohio
Version or Model: V1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6700-0270-700
Company Name: OHIO MEDICAL, LLC

Primary DI Number: 00628101612863
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005192885 *Terms of Use

Device Description: Venturi

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):	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?
63647	Pneumatic suction regulator/regulation set	A noninvasive device/collection of noninvasive devices designed to convert positive gas pressure from a compressed gas supply, into negative pressure (the Venturi principle) for the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). The device is designed to be connected to the gas supply (e.g., air, oxygen cannister) to achieve controlled continuous and/or intermittent suction at variable levels. It includes a manometer, an activation knob, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDP	REGULATOR, VACUUM

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: 3cfdfbcc-7d3b-4b4d-9731-382ba80d5ca8
Public Version Date: May 07, 2021
Public Version Number: 1
DI Record Publish Date: April 29, 2021

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: Yes
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: +1(847)855-6218
Email: customer.service@ohiomedical.com

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