AccessGUDID - DEVICE: Haemonetics (10887691000543)

GUDID

Device Identifier (DI) Information

Brand Name: Haemonetics
Version or Model: PXL8K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAEMONETICS CORPORATION

Primary DI Number: 10887691000543
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057827420 *Terms of Use

Device Description: High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight Administration Set

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:	No
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?
35071	Blood transfusion filter	A microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAK	Microfilter, blood transfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K873667	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31372368-5b75-4706-922a-58320abdc558
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: March 15, 2022