FDA.reportPublic FDA data

M-Flex®

Primary DI
00816734020456
Brand
M-Flex®
Company
DIVERSATEK HEALTHCARE, INC.
Model
1207-10
Catalog number
1207-10
Device description
Blue Silicone Tungsten Hurst Bougie Mini-Set
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816734020456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816734020456008167340204568167340204560816734020456

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal bougie, reusableA cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store flat, do not hang

Sterilization Methods#

Method table
Method
High-level Disinfectant;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816734023515BullDog®1203-401203-402025-12-05
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16
00816734023457Diversatek HealthcareHRIMSD-KITHRIMSD-KIT2025-05-16
00816734023464Diversatek HealthcareHRAM-KITHRAM-KIT2025-05-16
00816734023471Diversatek HealthcareEMG-KITEMG-KIT2025-05-16
00816734023488Diversatek HealthcareCOMP-KITCOMP-KIT2025-05-16
00816734023426Zvu®ZVU-3 Revision 3.4.0ZVU-32025-03-26
10816734023416BullDog®1203-931203-932024-11-22
M78312011101Diversatek Healthcare1201-1101201-1102024-10-31
10816734023362EZ-Ject1186-011186-012024-07-18
10816734023379EZ-Ject1186-021186-022024-07-18
10816734023386EZ-Ject1186-031186-032024-07-18
10816734023393EZ-Ject1186-041186-042024-07-18
M78312011081Diversatek Healthcare1201-1081201-1082024-06-07
M78312011061Diversatek Healthcare1201-1061201-1062024-01-31
10816734023355BullDog®1203-611203-612023-08-25
00816734023181SafeGuide® Single1215-151215-152023-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461EGCT400EndolumikEndolumik, Inc.FAT2023-05-15
24026704719536PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719543PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719550PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719567PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719574PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719581PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719598PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719604PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719611PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719628PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719635PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719642PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719659PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719666PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719673PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719680PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719697PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719703PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719710PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719727PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719734PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719741PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719758PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719765PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719772PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719789PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719796PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719802PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719819PILLINGTELEFLEX INCORPORATEDFAT2021-03-11