RediFoam™ MTFA39B
GUDID 00841439110928
Two-part Foaming Agent Part A (12.8oz) and Foaming Agent Part R (15oz)
MEDTEC, INC.
Patient positioning foam mould kit| Primary Device ID | 00841439110928 |
| NIH Device Record Key | cde4c318-7907-4d34-8cd1-45a6d228f8fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RediFoam™ |
| Version Model Number | MTFA39B |
| Catalog Number | MTFA39B |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Dimensions
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439110928 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K951808
FDA Product Code
| IYE | Accelerator, linear, medical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-06-14 |
| Device Publish Date | 2017-08-02 |
On-Brand Devices [RediFoam™]
| 00841439110928 | Two-part Foaming Agent Part A (12.8oz) and Foaming Agent Part R (15oz) |
| 00841439110911 | Two-part Foaming Agent Part A (15.8oz) and Foaming Agent Part R (19.2oz) |
| 00841439110904 | Two-part Foaming Agent Part A (21.8oz) and Foaming Agent Part R (24.6oz) |
Trademark Results [RediFoam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDIFOAM 87748673 not registered Live/Pending |
GOJO Industries, Inc. 2018-01-09 |
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