FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304011125
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
535C-ML6-CF
Catalog number
535C-ML6-CF
Device description
ML6 CYL W/CF REG FOR CANADA
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053240000DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIESSunrise Medical2006-02-03CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304011125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304011125008853040111258853040111250885304011125

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-regulator oxygen cylinderA container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-338-1988somdhccustomerservice@devilbisshc.com

Regulatory Flags#

DUNS number
962175894
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885304032502DeVilbiss125K-XB2020-05-27
03664390148857DeVilbissMQ5890-EU2020-05-21
00885304003816DeVilbissEX3000D-6522021-04-16
00822384002025DeVilbissDV54SE2020-04-03
00885304000280DeVilbiss9354DR2020-04-03
00885304000822DeVilbiss3655LTPL-REL2020-04-03
00885304000990DeVilbiss7310PD-PS2020-04-03
00885304001164DeVilbissDV51D-HH-S2020-04-03
00885304001508DeVilbiss3655PL-JCMH2020-04-03
00885304002338DeVilbiss7305D-D2020-04-03
00885304002598DeVilbiss535D-C-CF-RE2020-04-03
00885304002635DeVilbiss535D-E-8702020-04-03
00885304002970DeVilbissPD1000A-ML6-RE2020-04-03
00885304008798DeVilbissDV57D-HH-S-HT2020-04-03
00885304022473DeVilbiss1025KS2020-04-03
00885304007142DeVilbiss3655D-6032020-02-11
00885304007197DeVilbissPD1000D-6072020-02-11
00885304007463DeVilbissDV5C-6012020-02-11
00885304006763DeVilbissDV5C-6142020-02-10
00885304002482DeVilbiss5650D-6012020-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970384252163SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360078HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360085HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360092HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
16970384252160SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
26970384252167SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360061HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-27
00841447114635Invacare® Platinum Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
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00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
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00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
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00860012953301MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
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