FDA.reportPublic FDA data

A Plus

Primary DI
00683534810026
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
BB-3040-1S
Device description
Baby Blanket , Style: Stripes, Steam Pretreatment, 12Pc(s)/Polybag, 72Pc(s)/Case
Published
2022-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80683534810022PackageGS172In Commercial Distribution
00683534810026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8068353481002280683534810022
00683534810026006835348100266835348100260683534810026

GMDN Terms#

Term, Definition table
TermDefinition
Infant blanket, single-useA piece of fabric material intended to be used to wrap newborns/infants to retain their body heat and/or absorb fluids. 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 single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization"", ""Radiation Sterilization""]"

Regulatory Flags#

DUNS number
191705904
Device count
1
Premarket exempt
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00683534820513A Plus19206-JB2022-10-19
00683534820544A Plus1OR-1740-JB2022-10-19
00683534040010A Plus144-0040-8718-32024-01-18
00683534040027A Plus144-0040-8719-12024-01-18
00683534040034A Plus170-2004-4277-32024-01-18
00683534090336RegardA3PMSKUL4-REG2025-08-06
00683534090343RegardA3PMSKUL4-REG2025-08-06
00683534850015A Plus1SEP1525-12022-10-19
00683534850022A Plus1SNA0304-12022-10-19
00683534850039A Plus1SAB0810-12022-10-19
00683534850046A Plus1SAB0875-12022-10-19
00683534850053A Plus1AB0509-N2022-10-19
00683534850060A Plus1AB0810-N2022-10-19
00683534850077A Plus1AB0875-N2022-10-19
00683534850084A Plus1NG-2204-32022-10-19
00683534850091A Plus1NG-3304-32022-10-19
00683534850107A Plus1NG-4404-32022-10-19
00683534850114A Plus1SDR4406-22022-10-19
00683534850121A Plus1SIV2206-22022-10-19
00683534850138A Plus1NG-2203-32022-10-19

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Primary DI, Brand, Company table
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16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
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