DEVICE: N/A (00607411930379)

Device Identifier (DI) Information

N/A
LW-102
In Commercial Distribution
LW-102-0-35
SALTER LABS
00607411930379
GS1

1
022721133 *Terms of Use
Luma Wrap, small
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
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?
10417 Infant blanket, reusable
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PDH blanket, neonatal phototherapy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142416 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Small
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Device Record Status

d6bce6e6-60d2-40fd-9792-9a348c0c2d47
July 06, 2018
3
January 30, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20607411930373 100 00607411930379 In Commercial Distribution
10607411930376 25 00607411930379 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)421-0024
customercare@salterlabs.com
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