AccessGUDID - DEVICE: VAMP PLUS (07460691944824)

GUDID

Brand Name: VAMP PLUS
Version or Model: VP1
Catalog Number: VP1
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691944824
Issuing Agency: GS1
Device Count: 1

Device Description: BLOOD MANAGEMENT SYSTEM.

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.

Product Code	Product Code Name
KRA	Catheter, continuous flush

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.

Size Type Text
Length: 60 Inch

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 03, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
57460691944829	10	07460691944824		In Commercial Distribution	Shipper

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Phone: +1(800)822-9637
Email: tech_support@edwards.com