AccessGUDID - DEVICE: Lifeshield (10887787007227)

GUDID

Device Identifier (DI) Information

Brand Name: Lifeshield
Version or Model: 1492365
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1492365
Company Name: HOSPIRA, INC.

Primary DI Number: 10887787007227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141588017 *Terms of Use

Device Description: LIFESHIELD LATEX-FREE 100 mL BURETTE SET, Convertible Pin, 122 Inch with Prepierced and CLAVE Injection Sites, Dual Channel Cassette with Capped Secondary Port and OPTION-LOK, MICRODRIP SOLUSET

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?
12159	Burette intravenous administration set	A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system, that includes a calibrated burette for fluid volume measurement. The collection also typically includes tubing, connectors, clamps, and injection ports. It may be used for gravitational intravenous administration or with an infusion pump. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, infusion

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: 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 : 13.0 Milliliter
Device Size Text, specify: Drop Size : 60 Drops / Milliliter

Device Record Status

Public Device Record Key: 5581f4ee-0f31-48a5-8b37-08877f0abf64
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016