N/A UTO275A

GUDID 10607411945738

Utopia NE Full Face Mask - LG (with Black Headgear), pack of 5

SALTER LABS

CPAP/BPAP face mask, single-use
Primary Device ID10607411945738
NIH Device Record Keyf565d7ca-b529-4fce-8020-6fcec144611a
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberUTO275A
Catalog NumberUTO275A
Company DUNS022721133
Company NameSALTER LABS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100607411945731 [Primary]
GS110607411945738 [Package]
Contains: 00607411945731
Package: [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-03

On-Brand Devices [N/A]

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10607411961295ETCO2 Filtered Sampling Line, 13'. With Nafion moisture reduction technology.
10607411961288ETCO2 Filtered Sampling Line, 6'. With Nafion moisture reduction technology.
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10607411961110ETCO2 Filtered Sampling Line, 6' length
10607411961080NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Double Tube
10607411961066VitalCheck Blood pressure cuff, reusable, small adult (20.5 - 28.5 cm) Double tube
10607411961059Nasal Cannula (adult) Salter Style with 7’ (2.1 m) supply tube
10607411961042Nasal Cannula (adult) Salter Style with 4’ (1.2 m) supply tube
10607411961035Oxygen Tubing with 1 standard connector (6 mm) and 1 male thread grip connector
10607411961028Oxygen Tubing with 1 standard connector (6 mm) and 1 male thread grip connector
10607411961011Oxygen Tubing with 2 standard connectors (6 mm) 25' (7.6 m)
10607411959650DuraCheck Blood pressure cuff, reusable, adult (16-28 CM), single tube
10607411959629StatCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - DoubleTube
10607411959612Salter Style® Nasal O2 Cannula (Neonatal), 7' (2.1 m) supply tube with thread grip
00607411952609Salter Style Nasal O2 Cannula (Infant), 7' (2.1 m) supply tube
10607411952590Salter Style® Nasal O2 Cannula (Premature), 7' (2.1 m) supply tube with thread grip
10607411952576Patient Kit
00607411952562Gas Sampling Line .050" ID x 120" Length PVC Male/Female Luer Lock Connectors 5.0u Hydrophobic F
10607411951296DuraCheck Blood pressure cuff, reusable, adult - Single Tube
10607411951203Patient Kit
10607411951197Patient Kit
10607411951173Adult. EtCO2/O2 Nasal Divided Cannula, SH342824
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00607411951145Adult. EtCO2/O2 Nasal Divided Cannula, SH34283
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10607411951098Patient Kit
10607411951074Patient Kit
10607411951036StatCheck Disposable Blood Pressure Cuff Child (11-22 cm) - Single Tube
10607411951005Patient Cannula Kit
00607411950988DuraCheck Blood pressure cuff, reusable, adult - Single Tube
10607411950961Gas Sampling Line .040" ID x 96" Length PVC
10607411950954Pediatric. O2/ETCO2 Filtered Nasal Divided Cannula
10607411950947Infant. ETCO2 Filtered Nasal Sampling Cannula
10607411950930Adult. ETCO2 Filtered Nasal Sampling Cannula
10607411950923Pediatric. O2/ETCO2 Filtered Nasal Divided Cannula
10607411950886Pediatric. ETCO2 Filtered Nasal Sampling Cannula
10607411950015Oxygen Tubing Kit
10607411950008Nasal Cannula (adult) Salter Style®, soft, with 7’ (2.1 m) supply tube
10607411947367Adult. EtCO2/O2 Oral/Nasal Divided Cannula, male threadgrip CO2 connector. Adaptor (22 mm I.D
10607411947350Adult. EtCO2/O2 Nasal Divided Cannula, male threadgrip CO2 connector. Adaptor 22 mm (ID) x 6 mm
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