AccessGUDID - DEVICE: Mityvac (00888937003079)

GUDID

Device Identifier (DI) Information

Brand Name: Mityvac
Version or Model: 10020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coopersurgical, Inc.

Primary DI Number: 00888937003079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: MitySoft Bell Cup Vacuum-Assist Delivery System

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:	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?
37792	Foetal vacuum extraction system cup, single-use	A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or 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 [?]
K913324	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 452d218a-18f3-46af-a05e-3cd8f1a898be
Public Version Date: February 28, 2024
Public Version Number: 6
DI Record Publish Date: August 30, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30888937003070	24	00888937003079		In Commercial Distribution	Case
20888937003073	12	00888937003079		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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