AccessGUDID - DEVICE: OR Pack -HMO and RF (00607567204560)

GUDID

Device Identifier (DI) Information

Brand Name: OR Pack -HMO and RF
Version or Model: BO-TOP 15200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701050647
Company Name: DATASCOPE CORP.

Primary DI Number: 00607567204560
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: HMO 7100 BO Coated Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir Blood Transfer Bag 1000 ml BO-RF 32 RotaFLow BC 140 Plus BMU Cell Ven 1/2 Prebypass filter w/o Vent Posous Media 3/8 x 1/2 Gas 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):	Yes
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?
35441	Cardiopulmonary bypass system blood tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1511f77e-8f85-4c18-87f6-5eb41eb4ff7b
Public Version Date: December 08, 2022
Public Version Number: 5
DI Record Publish Date: November 13, 2015