FDA.reportPublic FDA data

DeVilbiss

Primary DI
10885304000935
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
4650D
Catalog number
4650D
Device description
Compressor / Nebulizer
Published
2016-09-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885304000935PackageGS16In Commercial Distribution
00885304000938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088530400093510885304000935
00885304000938008853040009388853040009380885304000938

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
962175894
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
00885304032045DeVilbiss125D-XB125D-XB2024-12-16
00885304033219DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033226DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033240DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033257DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033516DeVilbiss125D-ARYA-XB125D-ARYA-XB2025-04-28
00885304000105DeVilbiss7310P-6037310P-6032024-11-08
00885304032557DeVilbiss7325D-D-EXF7325D-D-EXF2024-11-08
00885304032571DeVilbiss7325P-D-EXF7325P-D-EXF2024-11-08
00885304001676DeVilbiss3655PL-VA3655PL-VA2016-09-08
00885304022268DeVilbiss3655I3655I-AR2017-04-21
10885304001505DeVilbiss3655PL-JCMH Case3655PL-JCMH2016-09-07
00885304020882DeVilbissDV64EDV64E2016-09-23
00885304000044DeVilbissDV54NE-PDV54NE-P2016-09-23
00885304000082DeVilbiss1751752016-09-24
00885304000884DeVilbiss5650C5650C2016-09-14
00885304022480DeVilbiss1025UK1025UK2017-08-17
00853040002806DeVilbiss9354DR9354DR2016-09-24
00853040015080DeVilbiss3655PL-JCMH3655PL-JCMH2016-09-09
00853040023382DeVilbiss7305D-D7305D-D2016-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20197344154187MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
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20197344154200MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
20197344135575MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00887761974739Life2000HILL-ROM SERVICES PTE. LTD.BTI2024-05-24
10197344042814MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00887761973473Life2000HILL-ROM SERVICES PTE. LTD.BTI2024-02-13
10888277703759MedlineMEDLINE INDUSTRIES, INC.BTI2023-12-26
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08586014621407DK50 DSEKOM spol. s r.o.BTI2022-10-12
40884389106878MedlineMEDLINE INDUSTRIES, INC.BTI2022-08-04
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00810050862042MedPakLIFEPORT, LLCBTI2022-06-28
00810050861717MedPakLIFEPORT, LLCBTI2021-11-03
00195278366061EVairDATEX-OHMEDA INCBTI2021-10-29
00195278366078EVairDATEX-OHMEDA INCBTI2021-10-29
16974385150005AUPOYibin Junxin Electronics Technology Co., Ltd.BTI2021-06-28
16974385150012AUPOYibin Junxin Electronics Technology Co., Ltd.BTI2021-06-28
16974385150029AUPOYibin Junxin Electronics Technology Co., Ltd.BTI2021-06-28
16974385150036AUPOYibin Junxin Electronics Technology Co., Ltd.BTI2021-06-28
26972011720315EndoClot Air CompressorEndoClot Plus Co.,Ltd.BTI2021-06-23
40888277304735MedlineMEDLINE INDUSTRIES, INC.BTI2021-04-07