AccessGUDID - DEVICE: Panoscreen EXTEND (10888234002406)

GUDID

Device Identifier (DI) Information

Brand Name: Panoscreen EXTEND
Version or Model: 0002383
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234002406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.

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?
52543	Antibody identification panel reagent red blood cell IVD, kit, agglutination	A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QHT	Reagent Red Blood Cells

FDA Premarket Submission

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

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
Storage Environment Temperature: between 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9adb0473-c4df-4934-99fb-146fffb6b937
Public Version Date: October 31, 2019
Public Version Number: 1
DI Record Publish Date: October 23, 2019