AccessGUDID - DEVICE: Quelimmune (G62102100601)

GUDID

Device Identifier (DI) Information

Brand Name: Quelimmune
Version or Model: 02-1006-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02-1006-01
Company Name: SEASTAR MEDICAL INCORPORATED

Primary DI Number: G62102100601
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 100323889 *Terms of Use

Device Description: Clinical Kit, SCD-PED

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:	Yes
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?
47306	Apheresis system column, selective leukocyte adsorption	A sterile cylinder containing an adsorptive carrier (e.g., cellulose acetate beads) for the adsorption of select leukocytes (e.g., granulocytes and monocytes/macropahges and mostly excluding lymphocytes, or the reverse) during apheresis. It is placed in an extracorporeal, closed-circuit apheresis system where blood is pumped from the patient, through the cylinder, and then back to the patient devoid of select leukocytes. It is typically used to treat a leukocyte-mediated condition [e.g., chronic inflammatory diseases such as inflammatory bowel disease (IBD) or rheumatoid arthritis (RA)] or to harvest select leukocytes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QZV	Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1504d2c-1fcd-4b7d-9645-749ae564a130
Public Version Date: May 29, 2024
Public Version Number: 1
DI Record Publish Date: May 21, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: G621021006011 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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