AccessGUDID - DEVICE: Infusion Set (E261MMT11730)

GUDID

Device Identifier (DI) Information

Brand Name: Infusion Set
Version or Model: MMT1173
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOENGINEERING LABORATORIES SRL

Primary DI Number: E261MMT11730
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 447644969 *Terms of Use

Device Description: Pump Tubing 4x6mm

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
14301	Urological irrigation set	A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXQ	Cystometer, Electrical Recording

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
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: d64d1249-096f-4966-9025-de0227b57267
Public Version Date: December 17, 2024
Public Version Number: 1
DI Record Publish Date: December 09, 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
E261MMT11731	25	E261MMT11730		In Commercial Distribution	Shelf Box
E261MMT11732	2	E261MMT11731		In Commercial Distribution	Shipping box

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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