DEVICE: Sapphire (10887787007524)
Device Identifier (DI) Information
Sapphire
1639302
In Commercial Distribution
1639302
ICU MEDICAL FLEET SERVICES, LLC
1639302
In Commercial Distribution
1639302
ICU MEDICAL FLEET SERVICES, LLC
SAPPHIRE Primary Polyethylene Lined Light Resistant Set Microbore, 121 Inch
Device Characteristics
Labeling does not contain MRI Safety Information | |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MRZ | ACCESSORIES, PUMP, INFUSION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K171346 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room Temperature. Avoid Excessive Heat. Protect from Freezing |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Approximate priming volume : 4.1 Milliliter |
Length: 121 Inch |
Device Record Status
b75e8a67-ae3c-4ac3-88ad-1246ab0bbaf2
July 06, 2018
2
June 01, 2018
July 06, 2018
2
June 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20887787007521 | 50 | 10887787007524 | In Commercial Distribution | Corrugated Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M33516393020 |
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
[?]
+1(877)946-7747
uscustomercare@icumed.com
uscustomercare@icumed.com