AccessGUDID - DEVICE: HAEMONETICS ACP 215 SYSTEM (10812747015028)

GUDID

Device Identifier (DI) Information

Brand Name: HAEMONETICS ACP 215 SYSTEM
Version or Model: 00236-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAEMONETICS CORPORATION

Primary DI Number: 10812747015028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057827420 *Terms of Use

Device Description: RBC DE-GLYCEROL. SET 325ML BMB

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?
45520	Blood cell freeze/thaw system set	A sterile collection of devices intended to be used in a blood cell processing system to either prepare red blood cells for frozen storage (glycerolization), or deglycerolize and wash red blood cells after thawing (may also wash fresh red blood cells). The device typically consists of a bacteriological filter, solution lines, connection ports, and collection containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSW	SYSTEM, PROCESSING FOR FROZEN BLOOD

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK030062	0
BK040077	0
BK060008	0

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
Total Volume: 5 Liter
Total Volume: 325 Milliliter
Total Volume: 600 Milliliter

Device Record Status

Public Device Record Key: cc724c0e-ea97-4aee-b638-a9fcd778668f
Public Version Date: October 19, 2023
Public Version Number: 4
DI Record Publish Date: February 07, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30812747015022	20	10812747015028		In Commercial Distribution

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: +1(800)-537-2802
Email: pirdesk@Haemonetics.com

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