DEVICE: WomanCare Global Single-Valve Aspirator Accessory Kit (00853615006321)
Device Identifier (DI) Information
WomanCare Global Single-Valve Aspirator Accessory Kit
AK-SVS
In Commercial Distribution
WOMANCARE GLOBAL TRADING, INC.
AK-SVS
In Commercial Distribution
WOMANCARE GLOBAL TRADING, INC.
Accessory kits are bagged and each kit contains: collar stop, plunger, o-ring and 2cc silicone tube. The cap, collar stop and o-ring, as components, are suitable to be reused a maximum of 25 times.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
33577 | Abortion suction system collection bottle |
A component of an abortion (uterine) suction system designed to function as a trap to collect the products of conception from the uterus [the termination of early pregnancies (up to 12 weeks), the treatment of incomplete spontaneous abortions, the removal of retained afterbirth, menstrual regulation, or biopsy]. It is typically cylindrical in shape and connected to a wide bore tubing through which the removed material is suctioned. It may have an integrated filter made of woven textile that acts as a sieve and trap (blood passes through whilst solids are retained). This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HHI | System, Abortion, Vacuum |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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High-level Disinfectant |
Liquid Chemical |
Moist Heat or Steam Sterilization |
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Lubricant: 2cc tube |
Device Size Text, specify: Collar Stop length: 3 inches |
Device Size Text, specify: Ring Diameter: 1 inch |
Device Record Status
60be1228-64ce-48fd-8a9a-4cca3ef0e77e
March 29, 2018
2
September 17, 2016
March 29, 2018
2
September 17, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+1-858-314-4030
customerservice@womancareglobal.org
customerservice@womancareglobal.org