Chemo Vent

Primary DI
B21231502
Brand
Chemo Vent
Company
INTERNATIONAL MEDICAL INDUSTRIES INC.
Model
31-50
Catalog number
31-50
Device description
Venting Needle Filtered (Red) with 0.2 micron hydrophobic filter, 20 gauge x 1.5" stainless steel non-coring needle, packaged sterile, individual blis
Published
2016-08-22
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

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860434000CHEMO-VENTIntl. Medical Industries1986-02-12LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B21231502PackageHIBCC100In Commercial Distribution
B21231501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hydrophobic Luer filter, sterileA sterile device intended to be attached to equipment during a medical/surgical procedure and/or to a needle during drug preparation (i.e., vial venting) to prevent the transfer of microbes, particulates and aerosols while allowing passage of air/gas; its use is not dedicated to a specific type of medical equipment. It is a small plastic housing containing a hydrophobic filter with male and female Luer connections (Luer-lock or Luer-slip). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053469565
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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B21257731001Oral Tamper Evident Cap57-73-10057-73-1002022-12-22
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B21257751Oral Tamper Evident Cap57-7557-752016-09-23
B2125791R1Tamper Evident Cap with Male Luer Lock57-91 R57-91 R2020-02-13
B212NM57751Tamper Evident Cap for NeoMed Oral DispensersNM-57752018-06-20
B21273211Oral Tamper Evident Cap732173212016-10-14
B2125720501Male Luer Slip Plug57-20-5057-20-502026-01-23
B2125725QUVA1Tamper Evident Cap57-25 QUVA57-25 QUVA2026-01-23
B212576031Female NRFit Tip Cap57-60357-6032026-01-23
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B21257700G1Luer Lock Cap57700G57700G2026-01-23
B21257700R1Luer Lock Cap57700R57700R2026-01-23
B21257700V1Luer Lock Cap57700V57700V2026-01-23
B21257700W1Luer Lock Cap57700W57700W2026-01-23

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