AccessGUDID - DEVICE: CMI (H671101A1)

GUDID

Device Identifier (DI) Information

Brand Name: CMI
Version or Model: Vacuum Pump
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101A
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671101A1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Vacuum Pump, PN 101A, Non-Electrical (Manual), Blue, Can be Autoclaved & EO Gas Sterilized

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:	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?
46402	Foetal vacuum extraction system, manual, single-use	An assembly of hand-operated devices designed to facilitate the delivery of a foetus during vaginal childbirth or Caesarean section by enabling traction to be applied to the foetal head by means of a suction cup that is attached to the scalp. It typically consists of a cup with a soft inner liner to prevent tissue damage, a hand-operated pump, and a handle used to apply traction. It is typically used for dystocia, uterine inertia, maternal exhaustion, maternal/foetal distress. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDB	Extractor, Vacuum, Fetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K895446	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide

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: 1031933c-fc6c-4cf4-aca0-4a35ee4d73e8
Public Version Date: December 18, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016