AccessGUDID - DEVICE: MEDRAD® Intego PET Infusion System (00616258025360)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD® Intego PET Infusion System
Version or Model: Intego
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INT SYS 200
Company Name: BAYER MEDICAL CARE INC.

Primary DI Number: 00616258025360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058716649 *Terms of Use

Device Description: SYSTEM,INTEGO,INT SYS 200,4ED,WS (87978443)

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":	No
For Single-Use:	No
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?
13215	Bedside infusion pump, single-channel	An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100798	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 5 and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 57 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e341537a-9d95-4441-b264-89aa94691496
Public Version Date: May 11, 2023
Public Version Number: 1
DI Record Publish Date: May 03, 2023