AccessGUDID - DEVICE: Plasma Exchange Tubeset (00868465000115)

GUDID

Device Identifier (DI) Information

Brand Name: Plasma Exchange Tubeset
Version or Model: 066I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 066I
Company Name: ASAHI KASEI MEDICAL AMERICA INC.

Primary DI Number: 00868465000115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828593785 *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:	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?
47572	Apheresis system tubing set	A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K831747	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef67bfeb-2abe-4e5e-abdf-ae6acc5396d7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2015