GELFOAM-JMI™ Powder Kit
GUDID 00360793410104
Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)
PFIZER INC.
General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated| Primary Device ID | 00360793410104 |
| NIH Device Record Key | e1775fc1-a885-4251-bc37-380818d16536 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GELFOAM-JMI™ Powder Kit |
| Version Model Number | 1 g Powder |
| Company DUNS | 829076566 |
| Company Name | PFIZER 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 | true |
| 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
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00360793410104 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: N18286
FDA Product Code
| LMF | Agent, absorbable hemostatic, collagen based |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-05 |
Devices Manufactured by PFIZER INC.
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| 00305733010037 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 2CT |
| 00305733010075 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT |
| 00305733010389 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT |
| 00305733010396 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT |
| 00305733010969 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT |
| 00305733010983 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP 8CT + NECK/SHOULDER/WRIST 1CT |
Trademark Results [GELFOAM-JMI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELFOAM-JMI 87374475 5581577 Live/Registered |
Pharmacia & Upjohn Company LLC 2017-03-16 |
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