AccessGUDID - DEVICE: Sapphire (10887787007432)

GUDID

Device Identifier (DI) Information

Brand Name: Sapphire
Version or Model: 1638303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1638303
Company Name: ICU MEDICAL FLEET SERVICES, LLC

Primary DI Number: 10887787007432
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830767898 *Terms of Use

Device Description: SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch (previously Hospira product)

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?
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRZ	ACCESSORIES, PUMP, INFUSION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171346	000

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: Room Temperature. Avoid Excessive Heat. Protect from Freezing

Clinically Relevant Size

[?]

Size Type Text
Length: 122 Inch
Device Size Text, specify: Approximate priming volume : 8.8 Milliliter

Device Record Status

Public Device Record Key: 61187c6f-ece5-4fc3-9d98-78db391537ca
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: June 04, 2018