AccessGUDID - DEVICE: Ohio (00628101598617)

GUDID

Device Identifier (DI) Information

Brand Name: Ohio
Version or Model: HS-CS-AE-01009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HS-CS-AE-01009
Company Name: OHIO MEDICAL, LLC

Primary DI Number: 00628101598617
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005192885 *Terms of Use

Device Description: 2.491 FT HOSE ASMB USA OXY DF*OF C4 MRI

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
63209	General-gas low pressure tubing, reusable	A non-sterile length of flexible tube intended to conduct compressed medical gas typically from a cylinder to a respiratory medical device outside of a static clinical environment (e.g., emergency CPAP device); it is not dedicated for use with a specific gas. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 15 bar), having been reduced by a regulator from a high pressure. The tubing is available in various lengths, including standard coil lengths; it is not colour-coded. This is a reusable device.	Obsolete	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: 42786adc-8a14-4013-8c2f-fec55bff638f
Public Version Date: July 18, 2022
Public Version Number: 1
DI Record Publish Date: July 10, 2022

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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