FDA.reportPublic FDA data

N/A

Primary DI
00874750003433
Brand
N/A
Company
HANS RUDOLPH, INC.
Model
6500
Catalog number
113543
Device description
65 V2 EX SMALL 22ID STR 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

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874750003433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750003433008747500034338747500034330874750003433

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008171360277157450 RV2 MASK74502018412025-09-19
008171360276927450 RV2 MASK74501138822024-07-15
008171360277087450 RV2 MASK74501138852024-07-15
008171360276855530 3L SYRINGE5530CR20972024-07-02
008171360276615570 3L SYRINGE55701136212023-11-08
008171360276545570 3L SYRINGE55701139272023-08-21
008171360276475570 3L SYRINGE55701139282023-08-17
008171360276307450 RV2 MASK7450CC16022023-08-11
008171360276237000 CONNECTORS7000CC17062023-06-14
008171360267637000 CONNECTORS7000CC20862023-06-13
008171360276167450 RV2 MASK7450CC21002023-04-13
008171360276092700 NRBV2700CR20872023-04-07
008171360270677450 RV2 MASK7450DR1320A2023-04-05
008171360270747450 RV2 MASK7450CC20812023-04-05
008171360270817450 RV2 MASK7450CC20822023-04-05
008171360270987450 RV2 MASK7450CC17432023-04-05
008171360271047450 RV2 MASK7450CC20512023-04-05
008171360271117450 RV2 MASK7450DR1320C2023-04-05
008171360271287450 RV2 MASK7450CC18592023-04-05
008171360271357450 RV2 MASK74502018302023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850057117370RESPOND VentilatorCORVENT MEDICAL, INCCBK2026-01-06
00850057117387Flow SensorCORVENT MEDICAL, INCCBK2026-01-06
00850057117394RESPOND Exhalation ManifoldCORVENT MEDICAL, INCCBK2026-01-06
00850057117400Exhalation ValveCORVENT MEDICAL, INCCBK2026-01-06
00850057117417RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/CORVENT MEDICAL, INCCBK2026-01-06
00850057117424HEPA FiltersCORVENT MEDICAL, INCCBK2026-01-06
00850057117448Green Oxygen Hose, 8ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117455Oxygen Tubing with Connector, 7ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117462Cart, IV Power StripCORVENT MEDICAL, INCCBK2026-01-06
00850057117479Cart, IV Power Strip MountCORVENT MEDICAL, INCCBK2026-01-06
00850057117486Patient Circuit Arm ClipCORVENT MEDICAL, INCCBK2026-01-06
00850070543033Emergency Ventilator Complete PackageVentis Medical Inc.CBK2025-12-31
00853678006733pNeuton Model A with 6ft Patient CircuitAIRON CORPORATIONCBK2025-12-19
20197344102652MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102669MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102676MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102683MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102690MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102706MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477507F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477514F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477521F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480453F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CBK2025-12-02
06903053046022VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
06903053046060VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
10190752190535LTVVYAIRE MEDICAL, INC.CBK2025-08-26
00850018761413Internal Battery PM Upgrade USB DriveVENTEC LIFE SYSTEMS, INC.CBK2025-08-06