FDA.report

Portex

Primary DI
35019315022306
Brand
Portex
Company
Smiths Medical International Ltd
Model
100/199/060
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications

CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35019315022306PackageGS120In Commercial Distribution
55019315022300PackageGS16In Commercial Distribution
15019315022302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3501931502230635019315022306
5501931502230055019315022300
1501931502230215019315022302

GMDN Terms

TermDefinition
Conceptive cervical cap, reusableA flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device that is typically larger, but shallower, than a contraceptive cap. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
215591523
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
30351688423256Portex008430M2015-09-01
30351688423270Portex008430T2015-09-01
30351688423287Portex008431T2015-09-01
30351688424277Portex0084352015-09-01
30351688404002Portex0020002016-10-05
35019517223334PortexC45101816D-NL2020-06-12
35019517236679PortexC45101817D-NL2020-09-18
30351688403036Portex0077672016-10-05
30351688410249Portex0022202016-12-28
30351688410355Portex0077602016-10-05
30351688416128Portex0022232016-12-28
10351688003782Portex5120702015-07-29
30351688005896Portex5630902015-07-29
10351688017949Portex5120902015-07-29
10351688018670Portex5120602015-07-29
10351688018809Portex5121002015-07-29
30351688018858Portex5630802015-07-29
10351688036674Portex5120802015-07-29
30351688036715Portex5631002015-07-29
10351688037176Portex5020602015-07-29

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