FDA.report

n/a

Primary DI
00874750006571
Brand
n/a
Company
HANS RUDOLPH, INC.
Model
2230
Catalog number
112621
Device description
2230C 2WAY 22MMOD/15MMID PORTS
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CBPValve, Non-Rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00874750006571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750006571008747500065718747500065710874750006571

GMDN Terms

TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

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