FDA UDI In Commercial Distribution 🇺🇸 United States

Wire Watch™

DI: M710WW1D0 · Model: WW-1D · BIOTEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Wire Watch™
Primary DI
M710WW1D0
Version / Model
WW-1D
Company Name
BIOTEX, INC.
Labeler DUNS
969792050
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-07-03
Public Version
1
Public Version Date
2024-07-11
Public Version Status
New
Public Device Record Key
657b0c36-5de5-4aff-a81a-2aae1fe75fb0

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KGZ Accessories, Catheter

GMDN Terms

Code Name
34957 Surgical drape clip, reusable

Identifiers

Type ID
Primary M710WW1D0
Package M710WW1D30PK2

Customer Contacts

Phone
7137410111

Storage Conditions

Type
Handling Environment Humidity
Temperature Range
30 – 85 Percent (%) Relative Humidity
Type
Handling Environment Temperature
Temperature Range
-18 – 60 Degrees Celsius
Type
Storage Environment Humidity
Temperature Range
30 – 85 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-18 – 60 Degrees Celsius