FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304002765
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
PD1000A-D
Catalog number
PD1000A-D
Device description
iFill PulseDoes Cylinder D
Published
2016-09-15
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
NFBConserver, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304002765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304002765008853040027658853040027650885304002765

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-40 Degrees Celsius70 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
Serial number
true
Manufacturing date on label
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
00841447198093Invacare® Element™ Pneumatic ConserverINVACARE CORPORATIONNFB2026-09-22
10889483599556AirLife™AIRLIFENFB2025-02-19
10889483605783AirLife™AIRLIFENFB2025-02-19
30889483599550AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
30889483605787AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
10889483605806AirLife™AIRLIFENFB2025-02-18
30889483605800AirLife™Sunmed Group Holdings, LLCNFB2025-02-18
00850027043746Precision MedicalPrecision Medical, Inc.NFB2024-12-12
00822383024875SmartDose EvolutionINOVO, INC.NFB2024-11-07
50822383024870SmartDose EvolutionINOVO, INC.NFB2024-11-07
00850027997001DynarisIncoba LLCNFB2023-12-14
00822383504322DriveINOVO, INC.NFB2023-10-16
00822383018553EVOLUTION INOVO, INC.NFB2023-05-25
00822383515557Evolution™INOVO, INC.NFB2023-05-25
50822383018558EVOLUTION INOVO, INC.NFB2023-05-25
50822383515552Evolution™INOVO, INC.NFB2023-05-25
00822383018522EVOLUTION INOVO, INC.NFB2023-04-28
00822383018515DriveINOVO, INC.NFB2022-09-21
00814470020297BONSAI INOVO, INC.NFB2021-09-20
10080196193080MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10080196752287MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10190752115057Airlife™AIRLIFENFB2021-03-09
50190752115055Airlife™VYAIRE MEDICAL, INC.NFB2021-03-09
00855887006962Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-03-05
00855887006627Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-02-25
00854485007197ARES Nasal CannulaWatermark Medical, Inc.NFB2021-02-22
00822383274485driveDrive Devilbiss HealthcareNFB2020-07-01
00822383283814driveDrive Devilbiss HealthcareNFB2020-07-01
00822383284101driveDrive Devilbiss HealthcareNFB2020-07-01
00822383296401driveDrive Devilbiss HealthcareNFB2020-07-01