AccessGUDID - DEVICE: Regard™ (10194717102281)

GUDID

Device Identifier (DI) Information

Brand Name: Regard™
Version or Model: UR00854
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ROI CPS, LLC

Primary DI Number: 10194717102281
Issuing Agency: GS1
Commercial Distribution End Date: January 03, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 117174678 *Terms of Use

Device Description: No description.

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:	Yes
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?
10406	Bladder irrigation kit	A collection of sterile devices designed for the infusion of fluids used to flush and evacuate the bladder of urine and other particulate matter. It typically includes tubing, connectors, a syringe, a roller clamp and other items used to flush the bladder. It may also be indicated for use in such procedures as a cystoscopy or a transurethral resection (TUR) as a means of continuous bladder irrigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PPA	Bladder Irrigation Kit

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: Yes
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: d5ff25fc-8337-4c49-8ac6-981bb2b56328
Public Version Date: January 13, 2020
Public Version Number: 1
DI Record Publish Date: January 03, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20194717102288	10	10194717102281	2020-01-03	Not in Commercial Distribution

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

Customer Contact

[?]

No Customer Contact currently defined

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