AccessGUDID - DEVICE: Cetro America Ultrasound Transducer for IM77/AM67 (00852519007014)

GUDID

Device Identifier (DI) Information

Brand Name: Cetro America Ultrasound Transducer for IM77/AM67
Version or Model: 8031011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CETRO AMERICA INC

Primary DI Number: 00852519007014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196275197 *Terms of Use

Device Description: Replacement ultrasound transducer for Advanced Medical Systems/SpaceLabs medical IM77/AM67 fetal monitors.

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):	No
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?
37796	Foetal/maternal prenatal monitor	An electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050826	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59213909-de98-4632-a2c7-e436b643f540
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016