FDA.reportPublic FDA data

6450 RV2 MASK

Primary DI
00874750005543
Brand
6450 RV2 MASK
Company
HANS RUDOLPH, INC.
Model
6450
Catalog number
113824
Device description
6450 V2 PET MASK SPU HG/FLEXMA
Published
2018-11-07
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

Product Codes#

Code, Name table
CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874750005543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750005543008747500055438747500055430874750005543

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function valveA non-sterile, dedicated valve intended to be used with a parent device for the measurement/analysis of a patient's pulmonary function. It is typically used to control inspired/expired gas directional flow and assist in the inhalation and distribution of test gases. This is a reusable device.

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
20197344009609HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009616HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011473HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011480HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344042187HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
008171360277157450 RV2 MASKHANS RUDOLPH, INC.KGB2025-09-19
07045432118179Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118285Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119244Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118186Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432118230Pocket Mask, SP Blue (EN)Laerdal Medical ASKGB2025-08-25
07045432119282Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119305Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119329Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119770Pocket Mask, HC Yellow (EN)Laerdal Medical ASKGB2025-08-25
07045432119251Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119268Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119275Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119299Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119312Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119336Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
07045432119879Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29
07045432119947Pocket Mask O2, PB (EN)Laerdal Medical ASKGB2025-07-29
07045432120004Pocket Mask O2, SP Blue (EN)Laerdal Medical ASKGB2025-07-29
00840117345232Resp-O2 Non-Rebreather Elongated Mask, Pediatric, With Safety Vent, 7' (2.1m) Dynarex CorporationKGB2025-05-30
00840117345249Resp-O2 Non-Rebreather Elongated Mask, Adult, 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30
00840117345256Resp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant Dynarex CorporationKGB2025-05-30
00840117345263Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30