FDA.reportPublic FDA data

Clear-View Subcutaneous Infusion Set

Primary DI
M991CVS612102
Brand
Clear-View Subcutaneous Infusion Set
Company
NORFOLK MEDICAL
Model
Clear-View "Sub-Q"
Catalog number
CVS61210
Device description
25G x 9mm x 12" Clear-View "Sub-Q" Infusion Set
Published
2021-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870188000NORFOLK MEDICAL BUTTERFLY INFUSION SETNorfolk Medical Products, Inc.1987-02-10FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M991CVS612102PackageHIBCC8In Commercial Distribution
M991CVS612103PackageHIBCC4In Commercial Distribution
M991CVS612101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8476747075rgangireddy@norfolkmedical.com

Regulatory Flags#

DUNS number
013861471
Device count
1
DM exempt
true
Premarket exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M991IK312211Standard IntroducerStraight Wing TearawayIK312212015-09-01
M991IK512211Standard IntroducerStraight Wing TearawayIK512212015-09-01
M991IK522211Valved IntroducerFlowguardIK522212015-09-01
M991IK712211Standard IntroducerStraight Wing TearawayIK712212015-09-01
M991IK722211Valved IntroducerFlowguardIK722212015-09-01
M991IK812211Standard IntroducerStraight Wing TearawayIK812212015-09-01
M991CVS611101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS611102021-11-18
M991CVS612101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS612102021-11-18
M991CVS615101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS615102021-11-18
M991CVS622101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS622102021-11-18
M991CVS611102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS611102021-11-18
M991CVS615102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS615102021-11-18
M991CVS622301Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS622302021-11-04
M991SCIG331361Clear-View Multi-site Subcutaneous Infusion SetClearView™MSSCIG331362020-10-19
M991TH011001Tidal High-Flow Non-coring NeedleTidal-HFTH011002015-10-06
M991TH012001Tidal High-Flow Non-coring NeedleTidal-HFTH012002015-10-06
M991TH013001Tidal High-Flow Non-coring NeedleTidal-HFTH013002015-10-06
M991TH021001Tidal High-Flow Non-coring NeedleTidal-HFTH021002015-10-06
M991TH022001Tidal High-Flow Non-coring NeedleTidal-HFTH022002015-10-06
M991TH023001Tidal High-Flow Non-coring NeedleTidal-HFTH023002015-10-06

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