FDA.reportPublic FDA data

Medline

Primary DI
10080196193103
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
HCS2GOBATT
Catalog number
HCS2GOBATT
Device description
BATTERY, FOR HCS2GO
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031413000VIGORMIST COMPRESSOR NEBULIZERVega Technologies, Inc.2003-10-07BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196193103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019619310310080196193103

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

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
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11
10884389001677Teleflex/Hudson RCI540154012016-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00038214001773Pulmo-Mist CompressorNIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001780Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001797Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00762860000582OMBRA* Table Top Compressor System Trudell Medical InternationalBTI2025-11-06
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10197344135585MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154180MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00810050862745Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2024-01-11
00810050862707Utility Pedestal AssemblyLIFEPORT, LLCBTI2023-12-15
00810050862691Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-12-08
00810050862677Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-11-10
00810050862615Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862622Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862530Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862547Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862431Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-06-06
00810050862363Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862370Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07
00810050862332Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07