DEVICE: Sapphire (10887787007531)
Device Identifier (DI) Information
Sapphire
1640002
In Commercial Distribution
1640002
ICU MEDICAL FLEET SERVICES, LLC
1640002
In Commercial Distribution
1640002
ICU MEDICAL FLEET SERVICES, LLC
SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previously Hospira product)
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 |
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 |
---|
Length: 124 Inch |
Device Size Text, specify: Drop Size : 20 Drops / Milliliter |
Device Size Text, specify: Approximate priming volume : 54 Milliliter |
Device Record Status
06b4cb36-f573-4d7b-abf5-22aa55c83f23
July 06, 2018
2
May 31, 2018
July 06, 2018
2
May 31, 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 |
---|---|---|---|---|---|
20887787007538 | 48 | 10887787007531 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M33516400020 |
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