DEVICE: NA (04055207054116)

Device Identifier (DI) Information

NA
4170502
In Commercial Distribution
4170502
Richard Wolf GmbH
04055207054116
GS1

10
315304071 *Terms of Use
INSUFFLATION TUBE SET L 3M high-flow with heating coil and integrated hygiene filter, PVC, PACK=10 PCS, for insufflators 2235021, 2235031, 2235621 and 2235631, sterile, for single use
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Surgical irrigation tubing set, single-use A collection of sterile, flexible, single-bore, external tubing intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline solution) from its source (e.g., gravity feed bag, feed pump) to a site of surgical intervention and/or endoscopy; it is not intended to navigate through an anatomical lumen. The tubing typically includes associated items such as clamps, filters, spikes, and connectors; it may include a syringe or an integrated manual pump (e.g., a squeeze bulb). It does not include suction tubing and is not intended to aspirate the surgical/endoscopic site (i.e., not an irrigation/aspiration tubing set). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HIF INSUFFLATOR, LAPAROSCOPIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000180 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
Length: 3 Meter
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Device Record Status

deda716c-ca75-4fcd-b442-b4fad7e1fb54
July 06, 2018
3
June 28, 2017
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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
No Package DIs found
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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: 04055207054123 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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