DEVICE: INTERLINK/CONTROL-A-FLO (00085412002422)

Device Identifier (DI) Information

INTERLINK/CONTROL-A-FLO
2C6891
In Commercial Distribution
2C6891
BAXTER INTERNATIONAL INC.
00085412002422
GS1

1
005146311 *Terms of Use
Extension Set with CONTROL-A-FLO Regulator, Injection Site, Male Luer Lock Adapter with Retractable Collar
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Medical tubing clip/clamp, dial-calibrated A non-sterile manual device designed to control the infusion rate through gravity intravenous administration infusion sets. It typically consists of a mechanism that regulates the flow using a calibrated dial that permits control of the flow rate in a given range (e.g., from a few to 250 ml/h); it may also include a lateral clamp for temporary interruption of the infusion and/or a check valve to permit parallel infusion. The device is used in-line with gravity infusion administration sets. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121634 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

9975ed02-7276-4ab7-8d07-80b111fda349
July 06, 2018
3
September 24, 2016
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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
50085412002427 48 00085412002422 In Commercial Distribution CASE
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Secondary DI

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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)933-0303
Medinfo_medproducts@baxter.com
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