FDA.report

INT Stopper

Primary DI
04022495770004
Brand
INT Stopper
Company
B. BRAUN MEDICAL INC.
Model
418030
Catalog number
418030
Device description
Non-needlefree Intermittent Injection Cap
Published
2016-09-23
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

Contact Domains

Product Codes

CodeName
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04022495770004PrimaryGS10
04046964183423Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04022495770004040224957700044022495770004
04046964183423040469641834234046964183423

GMDN Terms

TermDefinition
Luer-formatted protective capA small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
100
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

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