AccessGUDID - DEVICE: ZAPR™ (G507ZAPR01000)

GUDID

Device Identifier (DI) Information

Brand Name: ZAPR™
Version or Model: ZAPR0100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZAPR0100
Company Name: Incell Corporation, LLC

Primary DI Number: G507ZAPR01000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965420953 *Terms of Use

Device Description: Red Blood Cell Lysing Buffer

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):	No
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?
61165	Blood cell lysis reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGK	Products, Red-Cell Lysing Products

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 100 Milliliter

Device Record Status

Public Device Record Key: 677f4e43-067d-4c8d-9119-ad389e658c59
Public Version Date: September 14, 2023
Public Version Number: 1
DI Record Publish Date: September 06, 2023

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: No Unit of Use DI Numbers Found 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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-364-1765
Email: info@incell.com

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