AccessGUDID - DEVICE: Ohio (00628101629434)

GUDID

Device Identifier (DI) Information

Brand Name: Ohio
Version or Model: HS-06UW-DHF2C4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HS-06UW-DHF2C4
Company Name: OHIO MEDICAL, LLC

Primary DI Number: 00628101629434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005192885 *Terms of Use

Device Description: 6 FT HS ASM US WAGD DH*F2 1/4'' COND

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?
42834	Vacuum hose	A length of reinforced colour-coded flexible tubing intended to be connected to a vacuum-producing medical device, medical equipment, or a medical system to channel incoming suction. It has a thick wall to prevent collapse due to the negative pressure of the vacuum and typically produced according to ISO5359. It is available in various lengths, including standard coil lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	TUBING, PRESSURE AND ACCESSORIES

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: 5d89b5dc-340c-49b4-9396-d92704026aae
Public Version Date: November 20, 2024
Public Version Number: 1
DI Record Publish Date: November 12, 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: 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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