DEVICE: Sapphire (10887787007531)

Device Identifier (DI) Information

Sapphire
1640002
In Commercial Distribution
1640002
ICU MEDICAL FLEET SERVICES, LLC
10887787007531
GS1

1
830767898 *Terms of Use
SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previously Hospira product)
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Device Characteristics

MR Unsafe
No
Yes
Yes
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?
35833 Electric infusion pump administration set, single-use
A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MRZ ACCESSORIES, PUMP, INFUSION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K171346 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Room Temperature. Avoid Excessive Heat. Protect from Freezing
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Clinically Relevant Size

[?]
Size Type Text
Length: 124 Inch
Device Size Text, specify: Drop Size : 20 Drops / Milliliter
Device Size Text, specify: Approximate priming volume : 54 Milliliter
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Device Record Status

06b4cb36-f573-4d7b-abf5-22aa55c83f23
July 06, 2018
2
May 31, 2018
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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
20887787007538 48 10887787007531 In Commercial Distribution case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC M33516400020
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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
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)946-7747
uscustomercare@icumed.com
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