FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00812564037442
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
129033
Catalog number
129033
Device description
Baby Blanket 5 Pack
Published
2019-05-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNCTable, Obstetric (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNCTable, Obstetric (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932035000NON-LINTING DELIVERY BLANKETAmsco Sterile Recoveries, Inc.1994-05-26KNC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812564037442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564037442008125640374428125640374420812564037442

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
069936106
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019800627NOVO Health Services, LLC1262681262682020-03-10
00812564030528NOVO Health Services, LLC120307120307B2018-09-24
00812564030634NOVO Health Services, LLC120424120424B2018-09-24
00812564030894NOVO Health Services, LLC120621120621D2018-09-24
00812564031914NOVO Health Services, LLC121168121168B2018-09-24
00812564032102NOVO Health Services, LLC121311121311G2018-09-24
00812564032300NOVO Health Services, LLC121705121705E2018-09-24
00812564033635NOVO Health Services, LLC124175124175B2018-09-24
00812564033741NOVO Health Services, LLC124255124255B2018-09-24
00812564033949NOVO Health Services, LLC124512124512C2018-09-24
00812564033956NOVO Health Services, LLC124513124513C2018-09-24
00812564033963NOVO Health Services, LLC124514124514C2018-09-24
00812564033970NOVO Health Services, LLC124515124515C2018-09-24
00812564033987NOVO Health Services, LLC124516124516F2018-09-24
00812564034380NOVO Health Services, LLC124922124922D2018-09-24
00812564034625NOVO Health Services, LLC1260611260612018-09-24
00812564034830NOVO Health Services, LLC126267126267B2018-09-24
00812564034977NOVO Health Services, LLC63206320D2018-10-01
00812564035066NOVO Health Services, LLC1273361273362018-09-24
00812564035103NOVO Health Services, LLC1273641273642018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761978164COMFORT PAD ASSEMBLYHILL-ROM, INC.KNC2020-07-15
00810019800405NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2020-01-30
00810019800016NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-07-15
00812564037244NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564037282NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564037312NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564035592NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00812564036513NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00812564039378NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00812564039651NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00887761000896Affinity® 4 Birthing BedHILL-ROM, INC.KNC2016-09-17
00887761995451Leg SupportHILL-ROM, INC.KNC2016-09-17
00887761995468Leg SupportHILL-ROM, INC.KNC2016-09-17
00887761995475Calf SupportHILL-ROM, INC.KNC2016-09-17
00887761995482Calf SupportHILL-ROM, INC.KNC2016-09-17
00887761995574Extension PadHILL-ROM, INC.KNC2016-09-17
00887761998346Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998353Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998360Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998377Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998384Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998391Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998407Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998414Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998421Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998438Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998445Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998452Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998469Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998476Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17