AccessGUDID - DEVICE: NA (07332414010867)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 6038020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101593
Company Name: GAMBRO DASCO SPA

Primary DI Number: 07332414010867
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428788780 *Terms of Use

Device Description: SP-C13 Accessory spike

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Haemodialysis tubing set, single-use	A collection of sterile items intended for the administration of haemodialysis. It will typically consist of a collection of tubing segments and, e.g., connectors or clamps, required to transport blood or other fluids from a patient's vascular access device to the appropriate dialyser (haemodialyser) unit for processing. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KOC	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K823707	000

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 32 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Special Storage Condition, Specify: Must be stored in a dry place. Keep dry
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00beb62a-2520-4345-acf2-c637f4e27b8e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 28, 2016