AccessGUDID - DEVICE: XCELL (B708ACDA130)

GUDID

Device Identifier (DI) Information

Brand Name: XCELL
Version or Model: ACD-A-13
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APEX BIOLOGIX , LLC

Primary DI Number: B708ACDA130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079560357 *Terms of Use

Device Description: ACD-A 13mL Vial Anticoagulant (PN 70-111)

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:	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?
46812	Blood storage solution, anticoagulation	A blood preservation fluid used during the collection and storage of blood and blood components in a healthcare and/or a blood bank facility (typically in a laboratory associated with the collection of blood or during apheresis procedures that result in the collection of blood), to prevent blood clotting. It is supplied in a container (e.g., a polypropylene bag) and is not for direct intravenous infusion. This is single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet And Plasma Separator For Bone Graft Handling

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temp, avoid freezing and excessive heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7199993-50ad-4d66-bf04-52e7a8c7fefd
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025

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: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 844-897-4910
Email: orders@apexbiologix.com

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