GIBI HD B-2036
GUDID 00850007764227
Gastrointestinal Boundary Identification and Sizing Tube 36 French
Reshape Lifesciences Inc.
Gastric calibration tube, non-sterile| Primary Device ID | 00850007764227 |
| NIH Device Record Key | 44f37904-6791-439a-a6ae-23a86878a0a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GIBI HD |
| Version Model Number | B-2036 |
| Catalog Number | B-2036 |
| Company DUNS | 144998551 |
| Company Name | Reshape Lifesciences Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007764227 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221898
FDA Product Code
| KNT | Tubes, Gastrointestinal (And Accessories) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-15 |
| Device Publish Date | 2022-08-07 |
On-Brand Devices [GIBI HD]
| 00850007764234 | Gastrointestinal Boundary Identification and Sizing Tube 40 French |
| 00850007764227 | Gastrointestinal Boundary Identification and Sizing Tube 36 French |
| 00850007764210 | Gastrointestinal Boundary Identification and Sizing Tube 32 French |
Trademark Results [GIBI HD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GIBI HD 97217392 not registered Live/Pending |
Reshape Lifesciences, Inc. 2022-01-13 |
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