AccessGUDID - DEVICE: Haemonetics EZ Prime (10887691000161)

GUDID

Device Identifier (DI) Information

Brand Name: Haemonetics EZ Prime
Version or Model: RCEZ1T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAEMONETICS CORPORATION

Primary DI Number: 10887691000161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057827420 *Terms of Use

Device Description: EZ Prime Self-Priming High Efficiency Leukocyte Reduction Filter Set for Single Unit Blood Transfusion

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?
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 [?]
K873666	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a5d17cc-262b-478e-a2fb-f9e1e8acc53f
Public Version Date: June 02, 2023
Public Version Number: 4
DI Record Publish Date: December 15, 2016