DEVICE: A Plus (00683534810019)
Device Identifier (DI) Information
A Plus
1
In Commercial Distribution
BB-3038-1S
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution
BB-3038-1S
A PLUS INTERNATIONAL INC.
Baby Blanket , Style: Stripes, Steam Pretreatment, 12Pc(s)/Polybag, 72Pc(s)/Case
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 58934 | Infant blanket, single-use |
A 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KME | Bedding, Disposable, Medical |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| Ethylene Oxide |
| Moist Heat or Steam Sterilization |
| Radiation Sterilization |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
d76a098a-6d75-4a93-ad97-0c097b5d7b00
October 27, 2022
2
October 18, 2022
October 27, 2022
2
October 18, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 80683534810015 | 72 | 00683534810019 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined