AccessGUDID - DEVICE: Endure (B531STS162020)

GUDID

Device Identifier (DI) Information

Brand Name: Endure
Version or Model: STS162021217
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STS16202
Company Name: ENDURE INDUSTRIES

Primary DI Number: B531STS162020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066087031 *Terms of Use

Device Description: Suction Connection Tubing, 2 meters, 1/4 inch internal diameter, Sterile

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):	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?
16779	Suction/irrigation tubing, single-use	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYY	Tube, Aspirating, Flexible, Connecting

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
Storage Environment Temperature: between 0 and 49 Degrees Celsius
Handling Environment Temperature: between 0 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: .25 Inch
Length: 2 Meter

Device Record Status

Public Device Record Key: 4475f73d-9861-48aa-b974-5d56eba722ae
Public Version Date: June 08, 2021
Public Version Number: 5
DI Record Publish Date: February 20, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B531STS162022	50	B531STS162020		In Commercial Distribution	Carton

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

[?]

Phone: 6072994971
Email: support@endureind.com

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