AccessGUDID - DEVICE: SURESTREAM (10886704072560)

GUDID

Device Identifier (DI) Information

Brand Name: SURESTREAM
Version or Model: 70029US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70029US
Company Name: Medos International Sàrl

Primary DI Number: 10886704072560
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: Intraspinal Catheter Connector with Strain Relief Sleeve

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?
61493	Spinal port/catheter	A sterile implantable device intended to provide access to the subarachnoid (intrathecal) space of the spinal column for infusion (e.g., chemotherapeutic agents, pain relieving drugs) and/or drainage [e.g., cerebrospinal fluid (CSF)]. It consists of a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle, attached to a distal catheter which passes into the target site. It is made of metal [e.g., titanium (Ti)] and synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LKK	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890055	018
P890055	021
P890055	023
P890055	027
P890055	038

Device Exempt from Premarket Submission: No 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 15 and 25 Degrees Celsius
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 25 Degrees Celsius
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if opened or damaged.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b3f780cd-4ed3-4526-b00f-014e8467471e
Public Version Date: January 02, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 2014