N/A

Primary DI
00607411930379
Brand
N/A
Company
SALTER LABS
Model
LW-102
Catalog number
LW-102-0-35
Device description
Luma Wrap, small
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
10607411930376PackageGS125In Commercial Distribution
20607411930373PackageGS1100In Commercial Distribution
00607411930379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741193037610607411930376
2060741193037320607411930373
00607411930379006074119303796074119303790607411930379

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
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24
00607411006067N/ASO-1613-0SO-1613-02016-09-24
00607411006319N/ASO-1635-0SO-1635-02016-09-24
00607411006593N/AE7600-0E7600-02018-03-12
00607411006715N/ASO-1658-0SO-1658-02016-09-24
00607411006722N/ASO-1352SO-13522016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411007408N/ASO-1738-0SO-1738-02016-09-24
00607411007576N/ASO-500-0SO-500-02016-09-24
00607411007644N/ASO-1756-0SO-1756-02016-09-24
00607411007781N/ASO-1767-0SO-1767-02016-09-24
00607411007798N/ASO-1768-0SO-1768-02016-09-24
00607411009235N/ASO-1662-0SO-1662-02016-09-24
00607411009273N/ASO-1667-0SO-1667-02016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24

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
00607411930386N/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