DEVICE: Avaline Medical NJ LLC (00810077214855)
Device Identifier (DI) Information
Avaline Medical NJ LLC
VKDT x25
In Commercial Distribution
VKDT x25
Avaline Medical NJ Limited Liability Company
VKDT x25
In Commercial Distribution
VKDT x25
Avaline Medical NJ Limited Liability Company
Disposable Tourniquet 25
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
58128 | Limb tourniquet, manual, single-use |
A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAX | TOURNIQUET, NONPNEUMATIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
30a0e47d-baf6-48df-b56b-cdc8e4cf9081
July 06, 2022
1
June 28, 2022
July 06, 2022
1
June 28, 2022
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00810077216132
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(732)813-7799
204
jstein@avalinemedical.com
jstein@avalinemedical.com