FDA.report

N/A

Primary DI
00874750003402
Brand
N/A
Company
HANS RUDOLPH, INC.
Model
6500
Catalog number
113540
Device description
65 V2 LARGE 22ID STRGHT W/HG
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
true

Related Records

Product Codes

CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00874750003402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750003402008747500034028747500034020874750003402

GMDN Terms

TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
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
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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