DEVICE: N/A (04052536184514)

Device Identifier (DI) Information

N/A
XD 8002
In Commercial Distribution
XD 8002
Ulrich GmbH & Co. KG
04052536184514
GS1

1
315494757 *Terms of Use
Pump tubing - flex for ulrichINJECT CT injectors
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
61657 Electric infusion pump administration set, reusable
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 reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IZQ Injector, contrast medium, automatic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K171392 000
K192872 000
K210541 000
No CLOSE

Sterilization

Yes
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
No Device Sizes
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Device Record Status

aaedaa71-dee2-4c59-bf35-4568b655250c
June 08, 2022
2
March 12, 2019
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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
04052536184521 10 04052536184514 In Commercial Distribution
04052536184538 80 04052536184514 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

[?]
+4907319654152
safety@ulrichmedical.com
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