FDA.reportPublic FDA data

N/A

Primary DI
00607411930386
Brand
N/A
Company
SALTER LABS
Model
LW-103
Catalog number
LW-103-0-25
Device description
Luma Wrap, medium
Published
2017-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDHblanket, neonatal phototherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDHBlanket, Neonatal PhototherapyGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142416000Luma WrapSalter Labs2015-06-12PDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411930383PackageGS125In Commercial Distribution
20607411930380PackageGS1100In Commercial Distribution
00607411930386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741193038310607411930383
2060741193038020607411930380
00607411930386006074119303866074119303860607411930386

GMDN Terms#

Term, Definition table
TermDefinition
Infant blanket, reusableA piece of fabric material intended to be used to wrap newborns/infants to retain their body heat. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411919008Salter Labs® Adult Comfort Face Tent131032026-06-09
00607411919053Salter Labs® Oxygen Mask131242026-06-09
00607411919060Salter Labs® Oxygen Mask131252026-06-09
00607411919084MedTronic Cannula133012026-06-09
00607411919107Salter Labs® Nasal Cannula133072026-06-09
00607411919138Salter Labs® Nasal Cannula133102026-06-09
00607411919206MedTronic ETCo2 Cannula133402026-06-09
00607411919220Salter Labs® Oxygen Tubing134002026-06-09
00607411919237Salter Labs® Oxygen Tubing134042026-06-09
00607411919244Salter Labs® Oxygen Tubing134072026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)134082026-06-09
00607411919299MedTronic NebuTech135002026-06-09
00607411919329Salter Labs® NebuTech®135062026-06-09
00607411919350Salter Labs® Full Kit Nebulizer139512026-06-09
00607411000737N/A8900-148900-142016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B510PT3000ADVANCED PHOTOTHERAPY LAMP ADVANCED INSTRUMENTATIONS, INC.PDH2025-08-21
00859911004351BIONIX DEVELOPMENT CORPORATIONBionix, LLCPDH2017-02-22
00859911004368BIONIX DEVELOPMENT CORPORATIONBionix, LLCPDH2017-02-22
00859911004276Swaddler for PhototherapyBionix, LLCPDH2017-02-01
00859911004283Swaddler for PhototherapyBionix, LLCPDH2017-02-01
00607411930379N/ASALTER LABSPDH2017-01-30
00607411930393N/ASALTER LABSPDH2017-01-30
08599110040133BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040140BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040119BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040126BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25