AccessGUDID - DEVICE: Pall LeukoGuard BC2 (05034480306104)

GUDID

Device Identifier (DI) Information

Brand Name: Pall LeukoGuard BC2
Version or Model: BC2B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BC2B
Company Name: Pall International Sàrl

Primary DI Number: 05034480306104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485050483 *Terms of Use

Device Description: Pall LeukoGuard BC2 Blood Cardioplegia Filter

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":	Yes
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?
60834	Cardiopulmonary bypass system filter, blood/cardioplegia solution	A sterile, porous device intended to be incorporated into a blood/cardioplegia circuit during cardiopulmonary bypass to filter a mixture of oxygenated blood and crystalloid cardioplegia solution (e.g., 4:1 ratio) to remove/reduce potentially harmful gaseous emboli, aggregated blood constituents, particulate matter (e.g., greater than 40 microns), and leukocytes. It is typically a plastic housing with an input, output, and vent port containing a synthetic filter and leukocyte depleting media. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTM	Filter, blood, cardiopulmonary bypass, arterial line

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K902518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Reduce the level of leucocytes and exclude microemboli greater than 40 µm in size
Pore Size: 40 Micrometer

Device Record Status

Public Device Record Key: b0f45dc1-16c9-4309-aff7-a1f08844e26a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 21, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
35034480306105	10	05034480306104		In Commercial Distribution	case

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: Yes
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

[?]

Phone: +1(800)645-6578 ext: 5164843600
Email: EURegulatory@europe.pall.com

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