DEVICE: CMI (H671606TT0)
Device Identifier (DI) Information
CMI
Secure Cup
In Commercial Distribution
606TT
UTAH MEDICAL PRODUCTS, INC.
Secure Cup
In Commercial Distribution
606TT
UTAH MEDICAL PRODUCTS, INC.
OBSTETRICAL VACUUM DELIVERY SYSTEM, 63mm Secure Cup, w/ 6' Tube, Adapter, Vacuum Relief Valve
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HIS | Condom |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K910788 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 63 Millimeter |
Device Record Status
7870aeeb-c2d5-4b31-9075-eb0e492f1ecd
December 18, 2019
5
September 23, 2016
December 18, 2019
5
September 23, 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 |
---|---|---|---|---|---|
H671606TT1 | 10 | H671606TT0 | 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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-533-4984
customer@utahmed.com
customer@utahmed.com