FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344135575
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HCSFISHNEBRD
Catalog number
HCSFISHNEBRD
Device description
COMPRESSOR,NEBULIZER,FISH CHARACTER, RD
Published
2025-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
20197344135575PackageGS18In Commercial Distribution
10197344135578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734413557520197344135575
1019734413557810197344135578

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69 KiloPascal117 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761976283Life2000WELCH ALLYN, INC.BTI2026-02-09
00887761978041Life2000WELCH ALLYN, INC.BTI2026-02-09
20197344135599MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10888277417472MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
20197344135582MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
20197344154187MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
20197344154194MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
20197344154200MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
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
07325710001653Compressor Mini 115V 60HzMaquet Critical Care ABBTI2023-09-21
08586014625047DK50 DSEKOM spol. s r.o.BTI2023-06-14
00810050862417MedPakLIFEPORT, LLCBTI2023-05-24
00810050862387MedPakLIFEPORT, LLCBTI2023-03-27
08586014621407DK50 DSEKOM spol. s r.o.BTI2022-10-12
40884389106878MedlineMEDLINE INDUSTRIES, INC.BTI2022-08-04
0084011732400850 PSI CompressorDYNAREX CORPORATIONBTI2022-07-11
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
40888277304742MedlineMEDLINE INDUSTRIES, INC.BTI2021-04-07